Hypogonadism, Peripheral Vascular Disease, Type 2 Diabetes
Conditions
Keywords
Testosterone, Hypogonadism, Diabetes, PVD, RCT
Brief summary
There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.
Detailed description
Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.
Interventions
DRUGTestosterone
Sustanon- 200mg- Intramuscular testosterone every 2 weeks
DRUGsaline
Saline injection every two weeks
Sponsors
Barnsley Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes mellitus. 2. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism. 3. Peripheral vascular disease as defined by * previous diagnosis by a specialist vascular surgeon OR * ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene). 4. Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study. 5. Ability to give written informed consent after verbal and written explanation in the English language. 6. Ability to comply with all study requirements.
Exclusion criteria
1. Current or previous breast cancer. 2. Current or previous prostate cancer. 3. Raised prostate specific antigen (PSA) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion. 4. Severe symptoms of benign prostatic hypertrophy ('prostatism') 5. Treatment with testosterone in the 3 months prior to the trial. 6. Investigational drug treatment in the 3 months prior to the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Arterial Stiffness | Baseline, 12 weeks, and 26 weeks | The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in IMT | Baseline, 12 weeks, and 26 weeks | Progression of Carotid intima-media thickness measured in mm |
Countries
United Kingdom
Participant flow
Recruitment details
started 02/02/2006
Participants by arm
| Arm | Count |
|---|---|
| Active Testosterone 200 mg intramuscular every 2 weeks
Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks | 11 |
| Placebo Saline
saline: Saline injection every two weeks | 13 |
| Total | 24 |
Baseline characteristics
| Characteristic | Active | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 11.9 | 61.7 years STANDARD_DEVIATION 11.8 | 59.15 years STANDARD_DEVIATION 11.85 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 11 | 4 / 13 |
| serious Total, serious adverse events | 1 / 11 | 2 / 13 |
Outcome results
Primary
Change in Arterial Stiffness
The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist.
Time frame: Baseline, 12 weeks, and 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change in Arterial Stiffness | Baseline | 15.02 index β | Standard Deviation 5.74 |
| Active | Change in Arterial Stiffness | 12 weeks | 14.08 index β | Standard Deviation 5.36 |
| Active | Change in Arterial Stiffness | 26 weeks | 14.01 index β | Standard Deviation 4.53 |
| Placebo | Change in Arterial Stiffness | Baseline | 15.08 index β | Standard Deviation 6.59 |
| Placebo | Change in Arterial Stiffness | 12 weeks | 16.12 index β | Standard Deviation 7.42 |
| Placebo | Change in Arterial Stiffness | 26 weeks | 12.58 index β | Standard Deviation 5.55 |
Secondary
Change in IMT
Progression of Carotid intima-media thickness measured in mm
Time frame: Baseline, 12 weeks, and 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change in IMT | Baseline | 0.856 mm | Standard Deviation 0.132 |
| Active | Change in IMT | 12 weeks | 0.843 mm | Standard Deviation 0.137 |
| Active | Change in IMT | 26 weeks | 0.841 mm | Standard Deviation 0.135 |
| Placebo | Change in IMT | Baseline | 0.885 mm | Standard Deviation 0.13 |
| Placebo | Change in IMT | 12 weeks | 0.887 mm | Standard Deviation 0.12 |
| Placebo | Change in IMT | 26 weeks | 0.872 mm | Standard Deviation 0.124 |