Testosterone for Men With Insulin Treated Type 2 Diabetes

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349362
• Other study ID #: BDGH 264
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2006
• Last updated: March 29, 2010
• Start date: July 2006
• Est. completion date: October 2008

Study information

• Verified date: March 2010
• Source: Barnsley Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypogonadism

Intervention

Drug:
• Testosterone
Sustanon- 200mg intramuscular testosterone
• 0.9% saline
Saline intramuscular injection every two weeks

Locations

Country	Name	City	State
United Kingdom	Barnsley Hospital NHS Foundation Trust	Barnsley	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Barnsley Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	The effect of testosterone on male hypogonadism as assessed by the Ageing Males Symptoms (AMS)		6 months
Secondary	The effect of testosterone on markers of vascular risk; blood pressure, serum lipid levels, weight, waist circumference, body fat percentage,		6 months
Secondary	urinary micro-albumin, tumour necrosis factor alpha, and highly sensitive C reactive protein levels in the study population.		6 months
Secondary	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