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NCT Number: NCT01560546

Testosterone Therapy of Men With Type 2 Diabetes Mellitus (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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Gonadal Disorders Hypogonadism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone

Drug

50 mg/dose/day for 24 weeks

Other names: Testim

Placebo

Drug

placebo on the skin for 24 weeks

Primary outcomes

  1. Lean body mass

    Time frame: approximately three years

    Accessed by DXA scanning

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Marianne Andersen

Other

Collaborators

  • Odense University Hospital

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 22, 2012
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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