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Testosterone for Men With Insulin Treated Type 2 Diabetes

This study is currently recruiting participants.
Verified by Barnsley Hospital, July 2007

Sponsored by: Barnsley Hospital
Information provided by: Barnsley Hospital
ClinicalTrials.gov Identifier: NCT00349362
  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 IV

MedlinePlus related topics:   Diabetes   

ChemIDplus related topics:   Testosterone    Methyltestosterone    Oxymesterone    Testosterone enanthate    Testosterone Propionate    Testosterone undecanoate    Insulin    Sodium chloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

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
Estimated Study Completion Date:   April 2008

Arms Assigned Interventions
ACTIVE: Experimental Drug: Testosterone
Sustanon- 200mg intramuscular testosterone
PLACEBO: Placebo Comparator 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

Contacts
Contact: Hugh Jones, BSc MD FRCP     01226 777947 ext 2212     Hugh.Jones@nhs.net    
Contact: Roger Stanworth     01226 730000 ext 2212     Roger.Stanworth@nhs.net    

Locations
United Kingdom, South Yorkshire
Barnsley Hospital NHS Foundation Trust     Recruiting
      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


Study ID Numbers:   BDGH 264
First Received:   July 6, 2006
Last Updated:   July 19, 2007
ClinicalTrials.gov Identifier:   NCT00349362
Health Authority:   United Kingdom: National Health Service

Study placed in the following topic categories:
Metabolic Diseases
Gonadal Disorders
Diabetes Mellitus
Endocrine System Diseases
Methyltestosterone
Insulin
Testosterone 17 beta-cypionate
Testosterone
Hypogonadism
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:
Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on October 10, 2008




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