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Testosterone for Men With Insulin Treated Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00349362
Recruitment Status : Completed
First Posted : July 7, 2006
Last Update Posted : March 30, 2010
Sponsor:
Information provided by:
Barnsley Hospital

Tracking Information
First Submitted Date  ICMJE July 6, 2006
First Posted Date  ICMJE July 7, 2006
Last Update Posted Date March 30, 2010
Study Start Date  ICMJE July 2006
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2006)
The effect of 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2006)
  • The effect of testosterone on ultrasound measured intima-media thickness of the common carotid artery in the study population
  • The effect of testosterone on male hypogonadism as assessed by the Ageing Males Symptoms (AMS)
  • The effect of testosterone on markers of vascular risk; blood pressure, serum lipid levels, weight, waist circumference, body fat percentage,
  • urinary micro-albumin, tumour necrosis factor alpha, and highly sensitive C reactive protein levels in the study population.
  • The effect of the CAG repeat polymorphism in exon 1 of the androgen receptor gene on the response of the study population to testosterone.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testosterone for Men With Insulin Treated Type 2 Diabetes
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Hypogonadism
  • Diabetes
Intervention  ICMJE
  • Drug: Testosterone
    Sustanon- 200mg intramuscular testosterone
  • Drug: 0.9% saline
    Saline intramuscular injection every two weeks
Study Arms  ICMJE
  • Experimental: Testosterone
    Testosterone injections- 200mg- every 2 weeks
    Intervention: Drug: Testosterone
  • Placebo Comparator: Placebo
    Normal saline injections- every two weeks
    Intervention: Drug: 0.9% saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 19, 2007)
40
Original Enrollment  ICMJE
 (submitted: July 6, 2006)
22
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00349362
Other Study ID Numbers  ICMJE BDGH 264
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Hugh Jones, Barnsley Hospital NHS Foundation Trust
Study Sponsor  ICMJE Barnsley Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hugh Jones, BSc MD FRCP Barnsley Hospital NHS Foundation Trust
PRS Account Barnsley Hospital
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP