Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)

November 13, 2013 updated by: Marianne Andersen

Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.

A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.

Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance.

Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Inadequate levels of androgens have been associated with an increased risk of chronic illnesses including obesity and diabetes. Moreover, testosterone treatment has been shown to increase lean body mass and lipid oxidation as well as insulin sensitivity in hypogonadal men.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Department of Endocrinology, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male gender age 50-70
  • Bioavailable testosterone < 7,3 nmol/L
  • Metformin treatment of T2DM for 3 months or more

Exclusion Criteria:

  • HbA1c > 9,0 %, BMI > 40 kg/m2, Haematocrit > 50%,
  • Known malignant disease, PSA > 3 ug/L, Nycturia > 3 times,
  • Abnormal routine blood samples,
  • Severe hypertension,
  • Significant EKG-changes,
  • Wish of parenthood,
  • Active mental illness,
  • former or present abuse,
  • Severe illness of heart-, lung- or kidney,
  • Primary or secondary hypogonadism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo for 24 weeks
Drug: Placebo
placebo on the skin for 24 weeks
Active Comparator: Testim
Drug: Testosterone
50 mg/dose/day for 24 weeks
Other Names:
  • Testim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lean body mass
Time Frame: approximately three years
Accessed by DXA scanning
approximately three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: three years
Euglycemic hyperinsulinaemic clamp
three years
Regional body composition and liver fat
Time Frame: three years
DXA- and MR-scans and spect
three years
Glucose and lipid oxidation
Time Frame: three years
Indirect calorimetry
three years
Myostatin and satellite cells
Time Frame: 8 years
Muscle biopsy
8 years
Inflammation
Time Frame: 8 years
Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.
8 years
Physical activity
Time Frame: three years
Questionaires
three years
Quality of life
Time Frame: three years
Questionaires
three years
Sexual function
Time Frame: Three years
Questionaires
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marianne Andersen

Collaborators

Odense University Hospital

Investigators

  • Principal Investigator: Marianne Andersen, MD, ph.d.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-002102-73

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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