Testosterone for Men With Insulin Treated Type 2 Diabetes

Barnsley Hospital

Status and phase: Completed; Phase 4

Conditions: Diabetes; Hypogonadism

Treatments: Drug: 0.9% saline; Drug: Testosterone

Study type: Interventional

Funder types: Other

Identifiers

NCT00349362

BDGH 264

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

Testosterone

Experimental group

Description:

Testosterone injections- 200mg- every 2 weeks

Treatment:

Drug: Testosterone

Placebo

Placebo Comparator group

Description:

Normal saline injections- every two weeks

Treatment:

Drug: 0.9% saline