Testosterone for Men With Insulin Treated Type 2 Diabetes

NCT00349362 | Completed Phase 4

• 1 other identifier: BDGH 264
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypogonadism; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Testosterone

EXPERIMENTAL

Testosterone injections- 200mg- every 2 weeks

Drug: Testosterone

Placebo

PLACEBO COMPARATOR

Normal saline injections- every two weeks

Drug: 0.9% saline

Interventions

Testosterone DRUG

Sustanon- 200mg intramuscular testosterone

Testosterone

0.9% saline DRUG

Saline intramuscular injection every two weeks

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barnsley Hospital: lead

Study Sites (1)

Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire, S75 2EP, United Kingdom

Location

MeSH Terms

Conditions

Hypogonadism; Diabetes Mellitus

Interventions

Testosterone; Saline Solution

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hugh Jones, BSc MD FRCP

  Barnsley Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2006
• First Posted: July 7, 2006
• Study Start: July 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 30, 2010

Record last verified: 2010-03

Locations

GB (1)