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

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ClinicalTrials.gov Identifier: NCT01560546
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : November 14, 2013
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hypogonadism Drug: Testosterone Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : March 2012
Primary Completion Date : May 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Lean body mass [ Time Frame: approximately three years ]
    Accessed by DXA scanning


Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: three years ]
    Euglycemic hyperinsulinaemic clamp

  2. Regional body composition and liver fat [ Time Frame: three years ]
    DXA- and MR-scans and spect

  3. Glucose and lipid oxidation [ Time Frame: three years ]
    Indirect calorimetry

  4. Myostatin and satellite cells [ Time Frame: 8 years ]
    Muscle biopsy

  5. Inflammation [ Time Frame: 8 years ]
    Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.

  6. Physical activity [ Time Frame: three years ]
    Questionaires

  7. Quality of life [ Time Frame: three years ]
    Questionaires

  8. Sexual function [ Time Frame: Three years ]
    Questionaires



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marianne Andersen, MD, ph.d., Odense University Hospital
ClinicalTrials.gov Identifier: NCT01560546     History of Changes
Other Study ID Numbers: 2011-002102-73
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents