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

This study has been completed.
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01560546
First received: March 20, 2012
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Hypogonadism
Drug: Testosterone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Lean body mass [ Time Frame: approximately three years ] [ Designated as safety issue: Yes ]
    Accessed by DXA scanning


Secondary Outcome Measures:
  • Insulin sensitivity [ Time Frame: three years ] [ Designated as safety issue: No ]
    Euglycemic hyperinsulinaemic clamp

  • Regional body composition and liver fat [ Time Frame: three years ] [ Designated as safety issue: Yes ]
    DXA- and MR-scans and spect

  • Glucose and lipid oxidation [ Time Frame: three years ] [ Designated as safety issue: No ]
    Indirect calorimetry

  • Myostatin and satellite cells [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    Muscle biopsy

  • Inflammation [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.

  • Physical activity [ Time Frame: three years ] [ Designated as safety issue: No ]
    Questionaires

  • Quality of life [ Time Frame: three years ] [ Designated as safety issue: No ]
    Questionaires

  • Sexual function [ Time Frame: Three years ] [ Designated as safety issue: No ]
    Questionaires


Enrollment: 43
Study Start Date: March 2012
Study Completion Date: November 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Testim Drug: Testosterone
50 mg/dose/day for 24 weeks
Other Name: Testim
Placebo Comparator: Placebo
Placebo for 24 weeks
Drug: Placebo
placebo on the skin for 24 weeks
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560546

Locations
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Marianne Andersen
Odense University Hospital
Investigators
Principal Investigator: Marianne Andersen, MD, ph.d.
  More Information

No publications provided

Responsible Party: Marianne Andersen, MD, ph.d., Odense University Hospital
ClinicalTrials.gov Identifier: NCT01560546     History of Changes
Other Study ID Numbers: 2011-002102-73
Study First Received: March 20, 2012
Last Updated: November 13, 2013
Health Authority: Denmark: Ethics Committee

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 August 26, 2014