Testosterone for Men With Insulin Treated Type 2 Diabetes

Barnsley Hospital40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypogonadism Diabetes

Interventions

TestosteroneDRUG

Sustanon- 200mg intramuscular testosterone

0.9% salineDRUG

Saline intramuscular injection every two weeks

Eligibility

Sex: MALEMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire, United Kingdom

Outcomes

Primary Outcomes

The effect of 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin.

Time frame: 6 months

Secondary Outcomes

The effect of testosterone on ultrasound measured intima-media thickness of the common carotid artery in the study population

Time frame: 6 months

The effect of testosterone on male hypogonadism as assessed by the Ageing Males Symptoms (AMS)

Time frame: 6 months

The effect of testosterone on markers of vascular risk; blood pressure, serum lipid levels, weight, waist circumference, body fat percentage,

Time frame: 6 months

urinary micro-albumin, tumour necrosis factor alpha, and highly sensitive C reactive protein levels in the study population.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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