Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism
Conditions
Brief summary
The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity .
Detailed description
The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity . This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic men with low testosterone levels and comparing them to diabetic men with low testosterone who are not treated with testosterone. These groups will also be compared with diabetic men who have normal testosterone levels
Interventions
DRUGandrogel
androgel 1%
DRUGplacebo
placebo
Sponsors
Solvay Pharmaceuticals
University at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
matching placebo
Eligibility
Sex/Gender
MALE
Age
31 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Males with age 30-60 years inclusive. * PSA \< 2.6 ng/ml or \< 3.75 ng/ml with a negative prostate biopsy in the last 6 months. * IPSS ≤ 19. The lower age limit was decided on the fact that in our study on hypogonadotrophic hypogonadism in type 2 diabetic patients, the youngest subject was 31 years old. The upper age limit has been restricted to 60 to avoid including subjects with significant age-related declines in testosterone concentrations.Subjects on thiazolidinediones, statins, ACE inhibitors, angiotensin receptor blockers or antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study. Subjects on insulin, metformin or sulfonylureas can participate in the study, provided that minimal changes are made to the doses during the study
Exclusion criteria
* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 2)Hemoglobin A1c \>10%; * h/o prostate carcinoma; * Hepatic disease (transaminase \> 3 times normal) or cirrhosis; * Renal impairment (serum creatinine \> 1.5); * HIV or Hepatitis C positive status; * Participation in any other concurrent clinical trial; * Any other life-threatening, non-cardiac disease; * Use of over the counter health supplements which contain androgens; * Use of an investigational agent or therapeutic regimen within 30 days of study. * Use of testosterone in the past * Hematocrit \> 50%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid Intima Media Thickness | 2 years | carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Function | 2 years | assessed by brachial artery Flow mediated dilatation (FMD in Centimeters) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Androgel androgel
androgel: androgel 1% | 13 |
| Placebo placebo gel
placebo: placebo | 12 |
| no Treatment eugonadal comparison arm | 22 |
| Total | 47 |
Baseline characteristics
| Characteristic | Placebo | Total | Androgel | no Treatment |
|---|---|---|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 10.2 | 59.3 years STANDARD_DEVIATION 6.6 | 66.2 years STANDARD_DEVIATION 5.7 | 50.1 years STANDARD_DEVIATION 7.8 |
| Body mass index (BMI) | 37.3 Kg/m2 STANDARD_DEVIATION 10.2 | 36.1 Kg/m2 STANDARD_DEVIATION 6.9 | 38.7 Kg/m2 STANDARD_DEVIATION 7.6 | 34.9 Kg/m2 STANDARD_DEVIATION 6.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 47 Participants | 13 Participants | 22 Participants |
| total testosteron | 241 ng/dl STANDARD_DEVIATION 57 | 337 ng/dl STANDARD_DEVIATION 105 | 218 ng/dl STANDARD_DEVIATION 102 | 465 ng/dl STANDARD_DEVIATION 152 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 22 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 22 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 22 |
Outcome results
Primary
Carotid Intima Media Thickness
carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm).
Time frame: 2 years
Population: the no treatment group measurement was collected only at baseline and not followed beyond that point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel | Carotid Intima Media Thickness | 0 months | 0.632 centimeters (cm) | Standard Deviation 0.115 |
| Androgel | Carotid Intima Media Thickness | 2 years | 0.695 centimeters (cm) | Standard Deviation 0.214 |
| Placebo | Carotid Intima Media Thickness | 0 months | 0.590 centimeters (cm) | Standard Deviation 0.127 |
| Placebo | Carotid Intima Media Thickness | 2 years | 0.580 centimeters (cm) | Standard Deviation 0.133 |
| no Treatment | Carotid Intima Media Thickness | 0 months | 0.595 centimeters (cm) | Standard Deviation 0.19 |
Secondary
Endothelial Function
assessed by brachial artery Flow mediated dilatation (FMD in Centimeters)
Time frame: 2 years
Population: the no treatment group was not followed beyond baseline so no 2 years data will be entered.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel | Endothelial Function | 0 months | 0.469 centimeters (cm) | Standard Deviation 0.054 |
| Androgel | Endothelial Function | 2 years | 0.440 centimeters (cm) | Standard Deviation 0.109 |
| Placebo | Endothelial Function | 0 months | 0.523 centimeters (cm) | Standard Deviation 0.119 |
| Placebo | Endothelial Function | 2 years | 0.483 centimeters (cm) | Standard Deviation 0.106 |
| no Treatment | Endothelial Function | 0 months | 0.474 centimeters (cm) | Standard Deviation 0.087 |