Testosterone for Men With Insulin Treated Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with insulin.

Detailed Description
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There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.

Official Title
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A Randomised Double Blind Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Replacement on Glycaemic Control and Arterial Wall Properties of Hypogonadal Men With Type 2 Diabetes Treated With Insulin

Conditions
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Hypogonadism, Diabetes

Intervention / Treatment
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* Drug: Testosterone
* Drug: 0.9% saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males over 40 years old type 2 diabetes treated with insulin serum testosterone less than 12nmol/L on 2 consecutive morning samples symptoms attributable to hypogonadism Exclusion Criteria: current or previous breast cancer current or previous prostate cancer raised prostate specific antigen or abdominal digital rectal examination suspicious of prostate cancer unless diagnosis excluded after specialist urology opinion and/or prostate biopsy severe symptoms of benign prostatic hypertrophy treatment with testosterone in the three months prior to the trial investigational drug treatment in the three months prior to the trial

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone<br>Testosterone injections- 200mg- every 2 weeks | Drug: Testosterone<br>* Sustanon- 200mg intramuscular testosterone<br>|
| Placebo Comparator: Placebo<br>Normal saline injections- every two weeks | Drug: 0.9% saline<br>* Saline intramuscular injection every two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |