Hypogonadism, Male, Physical Activity, Testosterone Deficiency
Conditions
Keywords
hypogonadism, aging male, strength training, physical activity, testosterone
Brief summary
This study examines the effect of 12-week strength training program with and without testosterone replacement therapy (TRT) on body composition, physical function, selected biochemical markers of metabolic health, molecular parameters of training adaptation and the quality of life patients with ADAM. The investigators believe, that strength training program performed 2 times per week for 12 weeks can improve body composition (decrease fat mass and gain lean mass), muscle strength, muscle power and general quality of life in all training groups. In addition, combination TRT and strength training could help decrease fat mass, improve BMI, cardio-respiratory fitness and thus provide optimal therapy combination for hypogonadal ageing males.
Detailed description
The study is 3 groups controlled 12-week study to assess the effect of testosterone replacement therapy (TRT) with strength training (ST) and strength training (ST) for hypogonadal participants without testosterone replacement therapy (NON-TRT) with control healthy eugonadal group, that is also engaged in strength training. Strength training protocol starts one week after all the pre-intervention testing. The intervention is performed at the Comenius University in Bratislava, Faculty of Physical Education and Sport (FSPORT CU) in Slovakia. The strength training protocol follows a modified resistance exercise program. The participants perform strength training sessions two times per week for 12 weeks. All training sessions are supervised and guided by professional coaches with university degree in sports training to ensure safety, technique and progression in training load, with a maximum of three participants per coach. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The participants are instructed to perform concentric action in 2 s and immediately after eccentric action in also 2 s. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press. Training equipment is provided by KOHI Leopoldov, Slovakia and Technogym, Italia. Clinical and muscle cellular outcomes are collected before the intervention (pre-testing assessments) and after the intervention (post-testing assessments). Post intervention measurements start 7 days after intervention and go up to 3 weeks after intervention. Clinical outcomes Body composition analysis is measured by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series. LBM(lean body mass) is measured in total body and separately for arms, legs and trunk. The changes in lower and upper body LBM are investigated separately because of differences in androgen sensitivity in leg muscles compared to neck, chest and shoulder muscles. Body weight is measured by bioimpedance scale, the height by stadiometer and waist circumference by tape. The body mass index is calculated. Biochemical outcomes Fasting morning venous blood is taken from 8:00 am to 10:00 am. The haematological and biochemical parameters analysed are Haemoglobin, hematocrits, leucocytes, thrombocytes, glucose, urea, sodium, potassium, calcium, ALAT, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, testosterone, oestrogen, LH, FSH, SHBG, albumin, bilirubin, total protein, CRP, insulin, PSA. Physical functioning Muscle strength is measured by novel portable isometric knee dynamometer (maximal voluntary contraction of isometric knee extension, isometric knee flexion), hand grip strength dynamometry by Camry Digital Hand Dynamometer, predicted 1RM leg press from multiple repetition maximum testing. Cardio-respiratory fitness is measured by The Single Stage Treadmill Walking Test on Woodway Pro Treadmill, 10-m fast walk and 10-m usual walk measured by Photocells. Quality of life The general health status is measured by The Short Form (36) Health Survey patient-reported survey of patient health (SF-36). In addition to that clinically investigating the health-related quality of life (HRQoL) and symptoms of aging men are measured by Aging Males' Symptom Scale (AMS). Muscle cellular outcomes Muscle biopsies are obtain from approximately 80% of the subjects included in the study. Participants not willing to undergo biopsy are still eligible for trial participation. With the participant in a supine position, a 5 mm Muscle Biopsy Cannula (Bergstrom-stille, Sweden) with manual suction is used to obtain muscle samples (200 mg), under local anaesthesia (Lidocain 2%,). Before the intervention the biopsy is obtained from the mid-section of the right musculus vastus lateralis, and after the intervention the biopsy is obtained 3 cm proximal to the pre-intervention biopsy.
Interventions
PROCEDUREStrength training
The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.
Sponsors
Norwegian School of Sport Sciences
Slovak Academy of Sciences
Comenius University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The study is 3 arms 12-week strength training program to assess the effect of testosterone replacement therapy (TRT) with strength training (ST) and strength training (ST) for hypogonadal patients without testosterone replacement therapy (NON-TRT) with control healthy eugonadal group, that is also engaged in strength training.
Eligibility
Sex/Gender
MALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients of secondary hypogonadism on testosterone replacement therapy, newly diagnosed patients of secondary hypogonadism.
Exclusion criteria
* Regular strength training, medical treating osteoporosis, abnormal digital rectal results, conditions which are medical contraindications (without adjusting state): diabetes mellitus, severe cardiac arrhythmia, uncontrolled hypertension, unstable angina pectoris, chronic obstructive pulmonary disease, epilepsy, unstable bone lesions with high risk of fracture, prostate cancer or abnormal serum PSA levels without adverse histological examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Lean Mass | 7 days before intervention, 7 days after intervention | Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Body Mass | 7 days before intervention, 7 days after intervention | Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series. |
| Change From Baseline in 10-m Usual Walk Test | 7 days before intervention, 7 days after intervention | Measured in seconds by Microgates Photocells and than calculated to meters per second. |
| Change From Baseline in 10-m Fast Walk Test | 7 days before intervention, 7 days after intervention | Measured in seconds by Microgates Photocells than calculated to meters per second |
| Change From Baseline in Handgrip Strength | 7 days before intervention, 7 days after intervention | Measured by Camry Digital Hand Dynamometer. |
| Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension | 7 days before intervention, 7 days after intervention | Measured by Portable Isometric Knee Dynamometer. |
| Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion | 7 days before intervention, 7 days after intervention | Measured by Portable Isometric Knee Dynamometer. |
| Change From Baseline in The Single Stage Treadmill Walking Test | 7 days before intervention, 7 days after intervention | This test is focused on calculated VO2max in ml.kg-1.min-1 from speed measured on Woodway Pro Treadmill. |
| Change From Baseline in Predicted One Repetition Maximum on Leg Press | 7 days before intervention, 7 days after intervention | One repetition maximum in kg on leg press is predicted from multiple repetition maximum testing and measured on Life Fitness Signature Series Leg Press machine. |
| Change From Baseline in Maximal Voluntary Contraction in Benchpress | 7 days before intervention, 7 days after intervention | Measured in N by FiTRO Force Plates. |
| Change From Baseline in Fat Mass | 7 days before intervention, 7 days after intervention | Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series. |
| Change From Baseline in Aging Males' Symptom (AMS) Scale | 7 days before intervention, 7 days after intervention | Measuring symptoms of ageing men by numeric score scale. The questionnaire has for each of the 17 item an option to check one of 5 degrees of severity (severity 1...5 points at the questionnaire). The composite scores for each of the three dimensions (sub-scales) is based on adding up the scores of the items of the respective dimensions. The composite score (total score) is the sum of the three dimension scores. Higher score means higher severity of symptoms. The minimum total score is 17 and the maximum is 85. |
| Change From Baseline in Metabolic Parameters | 7 days before intervention, 7 days after intervention | Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am \[69\] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum. |
| Change From Baseline in Liver Function Blood Parameters | 7 days before intervention, 14 days after intervention | Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am \[69\] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum. |
| Change From Baseline in Hormonal Parameters | 7 days before intervention, 14 days after intervention | Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am \[69\] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum. |
| Change From Baseline in Ions | 7 days before intervention, 14 days after intervention | Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am \[69\] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum. |
| Change From Baseline in CRP | 7 days before intervention, 14 days after intervention | Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am \[69\] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum. |
| Change From Baseline in Muscle Fiber Size | 7 days before intervention, 14 days after intervention | Muscle fiber size measured in um2. Analysis of the date are in progress. |
| Change From Baseline in Regulators of Muscle Fiber Size | 7 days before intervention, 14 days after intervention | Regulators of muscle fiber size - number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors, proteins involved in muscle hypertrophy. Analysis of the date are in progress. |
| Change From Baseline in The Short Form Health Survey (SF-36) | 7 days before intervention, 7 days after intervention | Patient-reported survey of patient health (SF-36), clinically investigating the health-related quality of life (HRQoL). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. |
Countries
Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypogonadal Males Without TRT Strength training
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press. | 6 |
| Hypogonadal Males With TRT Strength training and regular prescribed testosterone therapy given by participant urologist.
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press. | 8 |
| Healthy Eugonadal Males Strength training
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press. | 8 |
| Total | 22 |
Baseline characteristics
| Characteristic | Hypogonadal Males Without TRT | Hypogonadal Males With TRT | Healthy Eugonadal Males | Total |
|---|---|---|---|---|
| Age, Continuous | 48.41 years STANDARD_DEVIATION 7.9 | 43.03 years STANDARD_DEVIATION 2.9 | 50.11 years STANDARD_DEVIATION 5.1 | 47.07 years STANDARD_DEVIATION 7.15 |
| Race/Ethnicity, Customized Slovak | 6 participants | 8 participants | 8 participants | 22 participants |
| Region of Enrollment Slovakia | 6 participants | 8 participants | 8 participants | 22 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 8 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Change From Baseline in Lean Mass
Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Lean Mass | 2734 grams | Standard Deviation 1967 |
| Hypogonadal Males With TRT | Change From Baseline in Lean Mass | 499 grams | Standard Deviation 1566 |
| Healthy Eugonadal Males | Change From Baseline in Lean Mass | 2268 grams | Standard Deviation 2609 |
Secondary
Change From Baseline in 10-m Fast Walk Test
Measured in seconds by Microgates Photocells than calculated to meters per second
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in 10-m Fast Walk Test | 0.05 m/s | Standard Deviation 0.255 |
| Hypogonadal Males With TRT | Change From Baseline in 10-m Fast Walk Test | -0.1 m/s | Standard Deviation 0.172 |
| Healthy Eugonadal Males | Change From Baseline in 10-m Fast Walk Test | -0.13 m/s | Standard Deviation 0.253 |
Secondary
Change From Baseline in 10-m Usual Walk Test
Measured in seconds by Microgates Photocells and than calculated to meters per second.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in 10-m Usual Walk Test | 0 m/s | Standard Deviation 0.089 |
| Hypogonadal Males With TRT | Change From Baseline in 10-m Usual Walk Test | -0.06 m/s | Standard Deviation 0.146 |
| Healthy Eugonadal Males | Change From Baseline in 10-m Usual Walk Test | -0.05 m/s | Standard Deviation 0.136 |
Secondary
Change From Baseline in Aging Males' Symptom (AMS) Scale
Measuring symptoms of ageing men by numeric score scale. The questionnaire has for each of the 17 item an option to check one of 5 degrees of severity (severity 1...5 points at the questionnaire). The composite scores for each of the three dimensions (sub-scales) is based on adding up the scores of the items of the respective dimensions. The composite score (total score) is the sum of the three dimension scores. Higher score means higher severity of symptoms. The minimum total score is 17 and the maximum is 85.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Aging Males' Symptom (AMS) Scale | -4.83 score on a scale | Standard Deviation 7.41 |
| Hypogonadal Males With TRT | Change From Baseline in Aging Males' Symptom (AMS) Scale | -2.00 score on a scale | Standard Deviation 5.98 |
| Healthy Eugonadal Males | Change From Baseline in Aging Males' Symptom (AMS) Scale | -6.25 score on a scale | Standard Deviation 5.09 |
Secondary
Change From Baseline in CRP
Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am \[69\] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.
Time frame: 7 days before intervention, 14 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in CRP | 0.02 mg/l | Standard Deviation 9.4 |
| Hypogonadal Males With TRT | Change From Baseline in CRP | 0.13 mg/l | Standard Deviation 2.26 |
| Healthy Eugonadal Males | Change From Baseline in CRP | -1.67 mg/l | Standard Deviation 2.4 |
Secondary
Change From Baseline in Fat Mass
Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Fat Mass | -1969 grams | Standard Deviation 2526 |
| Hypogonadal Males With TRT | Change From Baseline in Fat Mass | -1263 grams | Standard Deviation 1920 |
| Healthy Eugonadal Males | Change From Baseline in Fat Mass | -755 grams | Standard Deviation 1514 |
Secondary
Change From Baseline in Handgrip Strength
Measured by Camry Digital Hand Dynamometer.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Handgrip Strength | -1.41 kg | Standard Deviation 4 |
| Hypogonadal Males With TRT | Change From Baseline in Handgrip Strength | 0.84 kg | Standard Deviation 2.12 |
| Healthy Eugonadal Males | Change From Baseline in Handgrip Strength | -0.02 kg | Standard Deviation 3.28 |
Secondary
Change From Baseline in Hormonal Parameters
Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am \[69\] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.
Time frame: 7 days before intervention, 14 days after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Hormonal Parameters | S-Cortisol | -32.93 nmol/l | Standard Deviation 103.28 |
| Hypogonadal Males Without TRT | Change From Baseline in Hormonal Parameters | S-Testosterone | 1.69 nmol/l | Standard Deviation 1.2 |
| Hypogonadal Males Without TRT | Change From Baseline in Hormonal Parameters | S-Insuline | 0.004 nmol/l | Standard Deviation 0.046 |
| Hypogonadal Males Without TRT | Change From Baseline in Hormonal Parameters | S-SHBG | 2.42 nmol/l | Standard Deviation 4.67 |
| Hypogonadal Males With TRT | Change From Baseline in Hormonal Parameters | S-SHBG | -1.35 nmol/l | Standard Deviation 6.1 |
| Hypogonadal Males With TRT | Change From Baseline in Hormonal Parameters | S-Testosterone | -0.50 nmol/l | Standard Deviation 3.51 |
| Hypogonadal Males With TRT | Change From Baseline in Hormonal Parameters | S-Cortisol | -44.60 nmol/l | Standard Deviation 140.83 |
| Hypogonadal Males With TRT | Change From Baseline in Hormonal Parameters | S-Insuline | 0.019 nmol/l | Standard Deviation 0.061 |
| Healthy Eugonadal Males | Change From Baseline in Hormonal Parameters | S-Testosterone | -1.99 nmol/l | Standard Deviation 2.59 |
| Healthy Eugonadal Males | Change From Baseline in Hormonal Parameters | S-Insuline | 0.006 nmol/l | Standard Deviation 0.023 |
| Healthy Eugonadal Males | Change From Baseline in Hormonal Parameters | S-SHBG | -2.93 nmol/l | Standard Deviation 6.55 |
| Healthy Eugonadal Males | Change From Baseline in Hormonal Parameters | S-Cortisol | 34.34 nmol/l | Standard Deviation 159.29 |
Secondary
Change From Baseline in Ions
Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am \[69\] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.
Time frame: 7 days before intervention, 14 days after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Ions | S-Potassium | 0.17 mmol/l | Standard Deviation 0.34 |
| Hypogonadal Males Without TRT | Change From Baseline in Ions | S-Chlorides | -1.47 mmol/l | Standard Deviation 2.5 |
| Hypogonadal Males Without TRT | Change From Baseline in Ions | S-Sodium | 0.08 mmol/l | Standard Deviation 1.26 |
| Hypogonadal Males With TRT | Change From Baseline in Ions | S-Potassium | 0.06 mmol/l | Standard Deviation 0.13 |
| Hypogonadal Males With TRT | Change From Baseline in Ions | S-Chlorides | -0.77 mmol/l | Standard Deviation 4.21 |
| Hypogonadal Males With TRT | Change From Baseline in Ions | S-Sodium | -0.15 mmol/l | Standard Deviation 1.31 |
| Healthy Eugonadal Males | Change From Baseline in Ions | S-Chlorides | -0.33 mmol/l | Standard Deviation 3.78 |
| Healthy Eugonadal Males | Change From Baseline in Ions | S-Sodium | -0.19 mmol/l | Standard Deviation 1.13 |
| Healthy Eugonadal Males | Change From Baseline in Ions | S-Potassium | 0.14 mmol/l | Standard Deviation 0.31 |
Secondary
Change From Baseline in Liver Function Blood Parameters
Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am \[69\] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.
Time frame: 7 days before intervention, 14 days after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Liver Function Blood Parameters | S-ALT | 0.19 µkat/l | Standard Deviation 0.49 |
| Hypogonadal Males Without TRT | Change From Baseline in Liver Function Blood Parameters | S-GMT | -0.13 µkat/l | Standard Deviation 0.23 |
| Hypogonadal Males Without TRT | Change From Baseline in Liver Function Blood Parameters | S-AST | 0.05 µkat/l | Standard Deviation 0.19 |
| Hypogonadal Males Without TRT | Change From Baseline in Liver Function Blood Parameters | S-ALP | 0.06 µkat/l | Standard Deviation 0.11 |
| Hypogonadal Males Without TRT | Change From Baseline in Liver Function Blood Parameters | S-AMS | 0.06 µkat/l | Standard Deviation 0.23 |
| Hypogonadal Males With TRT | Change From Baseline in Liver Function Blood Parameters | S-ALP | 0.05 µkat/l | Standard Deviation 0.11 |
| Hypogonadal Males With TRT | Change From Baseline in Liver Function Blood Parameters | S-ALT | -0.05 µkat/l | Standard Deviation 0.28 |
| Hypogonadal Males With TRT | Change From Baseline in Liver Function Blood Parameters | S-AMS | 0.05 µkat/l | Standard Deviation 0.08 |
| Hypogonadal Males With TRT | Change From Baseline in Liver Function Blood Parameters | S-AST | 0.00 µkat/l | Standard Deviation 0.19 |
| Hypogonadal Males With TRT | Change From Baseline in Liver Function Blood Parameters | S-GMT | 0.01 µkat/l | Standard Deviation 0.16 |
| Healthy Eugonadal Males | Change From Baseline in Liver Function Blood Parameters | S-AMS | 0.07 µkat/l | Standard Deviation 0.16 |
| Healthy Eugonadal Males | Change From Baseline in Liver Function Blood Parameters | S-ALP | 0.10 µkat/l | Standard Deviation 0.18 |
| Healthy Eugonadal Males | Change From Baseline in Liver Function Blood Parameters | S-GMT | -0.05 µkat/l | Standard Deviation 0.27 |
| Healthy Eugonadal Males | Change From Baseline in Liver Function Blood Parameters | S-ALT | -0.07 µkat/l | Standard Deviation 0.1 |
| Healthy Eugonadal Males | Change From Baseline in Liver Function Blood Parameters | S-AST | -0.01 µkat/l | Standard Deviation 0.04 |
Secondary
Change From Baseline in Maximal Voluntary Contraction in Benchpress
Measured in N by FiTRO Force Plates.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Maximal Voluntary Contraction in Benchpress | -6.49 N | Standard Deviation 147.12 |
| Hypogonadal Males With TRT | Change From Baseline in Maximal Voluntary Contraction in Benchpress | 64.31 N | Standard Deviation 143.29 |
| Healthy Eugonadal Males | Change From Baseline in Maximal Voluntary Contraction in Benchpress | 66.68 N | Standard Deviation 103.38 |
Secondary
Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension
Measured by Portable Isometric Knee Dynamometer.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension | -9.65 Nm | Standard Deviation 93.44 |
| Hypogonadal Males With TRT | Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension | 8.15 Nm | Standard Deviation 28.97 |
| Healthy Eugonadal Males | Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension | 1.35 Nm | Standard Deviation 69.5 |
Secondary
Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion
Measured by Portable Isometric Knee Dynamometer.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion | 2.32 Nm | Standard Deviation 27.89 |
| Hypogonadal Males With TRT | Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion | 24.64 Nm | Standard Deviation 36.09 |
| Healthy Eugonadal Males | Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion | 14.36 Nm | Standard Deviation 28.13 |
Secondary
Change From Baseline in Metabolic Parameters
Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am \[69\] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Metabolic Parameters | S-HDL Cholesterol | 0.06 mmol/l | Standard Deviation 0.1 |
| Hypogonadal Males Without TRT | Change From Baseline in Metabolic Parameters | S-Creatinine | -0.006 mmol/l | Standard Deviation 0.008 |
| Hypogonadal Males Without TRT | Change From Baseline in Metabolic Parameters | S-Glucose | 0.33 mmol/l | Standard Deviation 0.44 |
| Hypogonadal Males Without TRT | Change From Baseline in Metabolic Parameters | S-Total Cholesterol | 0.10 mmol/l | Standard Deviation 0.67 |
| Hypogonadal Males Without TRT | Change From Baseline in Metabolic Parameters | S-LDL Cholesterol | -0.06 mmol/l | Standard Deviation 0.52 |
| Hypogonadal Males Without TRT | Change From Baseline in Metabolic Parameters | S-Triglyceride | -0.20 mmol/l | Standard Deviation 0.46 |
| Hypogonadal Males Without TRT | Change From Baseline in Metabolic Parameters | S-Urea | -0.16 mmol/l | Standard Deviation 1.45 |
| Hypogonadal Males Without TRT | Change From Baseline in Metabolic Parameters | S-Uric Acid | -0.016 mmol/l | Standard Deviation 0.071 |
| Hypogonadal Males Without TRT | Change From Baseline in Metabolic Parameters | S-Bilirubin | 0.0006 mmol/l | Standard Deviation 0.0038 |
| Hypogonadal Males With TRT | Change From Baseline in Metabolic Parameters | S-LDL Cholesterol | -0.30 mmol/l | Standard Deviation 1.07 |
| Hypogonadal Males With TRT | Change From Baseline in Metabolic Parameters | S-Bilirubin | 0.0008 mmol/l | Standard Deviation 0.004 |
| Hypogonadal Males With TRT | Change From Baseline in Metabolic Parameters | S-Total Cholesterol | 0.22 mmol/l | Standard Deviation 0.71 |
| Hypogonadal Males With TRT | Change From Baseline in Metabolic Parameters | S-HDL Cholesterol | 0.09 mmol/l | Standard Deviation 0.17 |
| Hypogonadal Males With TRT | Change From Baseline in Metabolic Parameters | S-Uric Acid | 0.004 mmol/l | Standard Deviation 0.047 |
| Hypogonadal Males With TRT | Change From Baseline in Metabolic Parameters | S-Creatinine | -0.0002 mmol/l | Standard Deviation 0.0052 |
| Hypogonadal Males With TRT | Change From Baseline in Metabolic Parameters | S-Triglyceride | 0.38 mmol/l | Standard Deviation 1.27 |
| Hypogonadal Males With TRT | Change From Baseline in Metabolic Parameters | S-Urea | 3.77 mmol/l | Standard Deviation 8.58 |
| Hypogonadal Males With TRT | Change From Baseline in Metabolic Parameters | S-Glucose | 0.29 mmol/l | Standard Deviation 0.5 |
| Healthy Eugonadal Males | Change From Baseline in Metabolic Parameters | S-Triglyceride | 0.28 mmol/l | Standard Deviation 0.86 |
| Healthy Eugonadal Males | Change From Baseline in Metabolic Parameters | S-Urea | 0.84 mmol/l | Standard Deviation 1.26 |
| Healthy Eugonadal Males | Change From Baseline in Metabolic Parameters | S-Total Cholesterol | 0.29 mmol/l | Standard Deviation 1.11 |
| Healthy Eugonadal Males | Change From Baseline in Metabolic Parameters | S-HDL Cholesterol | 0.08 mmol/l | Standard Deviation 0.2 |
| Healthy Eugonadal Males | Change From Baseline in Metabolic Parameters | S-LDL Cholesterol | -0.12 mmol/l | Standard Deviation 0.84 |
| Healthy Eugonadal Males | Change From Baseline in Metabolic Parameters | S-Glucose | -0.02 mmol/l | Standard Deviation 0.65 |
| Healthy Eugonadal Males | Change From Baseline in Metabolic Parameters | S-Bilirubin | -0.003 mmol/l | Standard Deviation 0.006 |
| Healthy Eugonadal Males | Change From Baseline in Metabolic Parameters | S-Uric Acid | -0.010 mmol/l | Standard Deviation 0.053 |
| Healthy Eugonadal Males | Change From Baseline in Metabolic Parameters | S-Creatinine | 0.0011 mmol/l | Standard Deviation 0.0038 |
Secondary
Change From Baseline in Muscle Fiber Size
Muscle fiber size measured in um2. Analysis of the date are in progress.
Time frame: 7 days before intervention, 14 days after intervention
Secondary
Change From Baseline in Predicted One Repetition Maximum on Leg Press
One repetition maximum in kg on leg press is predicted from multiple repetition maximum testing and measured on Life Fitness Signature Series Leg Press machine.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Predicted One Repetition Maximum on Leg Press | 45.31 kg | Standard Deviation 28.39 |
| Hypogonadal Males With TRT | Change From Baseline in Predicted One Repetition Maximum on Leg Press | 51.59 kg | Standard Deviation 34.43 |
| Healthy Eugonadal Males | Change From Baseline in Predicted One Repetition Maximum on Leg Press | 51.40 kg | Standard Deviation 27.16 |
Secondary
Change From Baseline in Regulators of Muscle Fiber Size
Regulators of muscle fiber size - number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors, proteins involved in muscle hypertrophy. Analysis of the date are in progress.
Time frame: 7 days before intervention, 14 days after intervention
Secondary
Change From Baseline in The Short Form Health Survey (SF-36)
Patient-reported survey of patient health (SF-36), clinically investigating the health-related quality of life (HRQoL). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in The Short Form Health Survey (SF-36) | 2.50 score on a scale | Standard Deviation 9.87 |
| Hypogonadal Males With TRT | Change From Baseline in The Short Form Health Survey (SF-36) | 7.50 score on a scale | Standard Deviation 18.52 |
| Healthy Eugonadal Males | Change From Baseline in The Short Form Health Survey (SF-36) | 3.75 score on a scale | Standard Deviation 12.46 |
Secondary
Change From Baseline in The Single Stage Treadmill Walking Test
This test is focused on calculated VO2max in ml.kg-1.min-1 from speed measured on Woodway Pro Treadmill.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in The Single Stage Treadmill Walking Test | 0.61 ml.kg-1.min-1 | Standard Deviation 0.64 |
| Hypogonadal Males With TRT | Change From Baseline in The Single Stage Treadmill Walking Test | 0.25 ml.kg-1.min-1 | Standard Deviation 0.64 |
| Healthy Eugonadal Males | Change From Baseline in The Single Stage Treadmill Walking Test | 0.42 ml.kg-1.min-1 | Standard Deviation 0.54 |
Secondary
Change From Baseline in Total Body Mass
Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.
Time frame: 7 days before intervention, 7 days after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypogonadal Males Without TRT | Change From Baseline in Total Body Mass | 621.53 grams | Standard Deviation 2922.45 |
| Hypogonadal Males With TRT | Change From Baseline in Total Body Mass | -821.73 grams | Standard Deviation 3279.29 |
| Healthy Eugonadal Males | Change From Baseline in Total Body Mass | 1435.04 grams | Standard Deviation 3655.01 |