| Trial ID: | L5921 |
| Source ID: | NCT00349362
|
| Associated Drug: |
Testosterone
|
| Title: |
Testosterone for Men With Insulin Treated Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypogonadism|Diabetes
|
| Interventions: |
DRUG: Testosterone|DRUG: 0.9% saline
|
| Outcome Measures: |
Primary: The effect of 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin., 6 months | Secondary: The effect of testosterone on ultrasound measured intima-media thickness of the common carotid artery in the study population, 6 months|The effect of testosterone on male hypogonadism as assessed by the Ageing Males Symptoms (AMS), 6 months|The effect of testosterone on markers of vascular risk; blood pressure, serum lipid levels, weight, waist circumference, body fat percentage,, 6 months|urinary micro-albumin, tumour necrosis factor alpha, and highly sensitive C reactive protein levels in the study population., 6 months|The effect of the CAG repeat polymorphism in exon 1 of the androgen receptor gene on the response of the study population to testosterone., 6 months
|
| Sponsor/Collaborators: |
Sponsor: Barnsley Hospital
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-07
|
| Completion Date: |
2008-10
|
| Results First Posted: |
|
| Last Update Posted: |
2010-03-30
|
| Locations: |
Barnsley Hospital NHS Foundation Trust, Barnsley, South Yorkshire, S75 2EP, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00349362
|