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Testosterone for Men With Insulin Treated Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Barnsley Hospital
ClinicalTrials.gov Identifier:
NCT00349362
First received: July 6, 2006
Last updated: March 29, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypogonadism
Diabetes
 Drug: Testosterone
Drug: 0.9% saline
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barnsley Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: July 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Testosterone
Testosterone injections- 200mg- every 2 weeks
 Drug: Testosterone
Sustanon- 200mg intramuscular testosterone
Placebo Comparator: Placebo
Normal saline injections- every two weeks
 Drug: 0.9% saline
Saline intramuscular injection every two weeks

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349362

Locations
United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, United Kingdom, S75 2EP
Sponsors and Collaborators
Barnsley Hospital
Investigators
Principal Investigator: Hugh Jones, BSc MD FRCP Barnsley Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Prof Hugh Jones, Barnsley Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00349362     History of Changes
Other Study ID Numbers: BDGH 264
Study First Received: July 6, 2006
Last Updated: March 29, 2010
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypogonadism
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gonadal Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
 Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 23, 2013