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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560546
First Posted: March 22, 2012
Last Update Posted: November 14, 2013
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.
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital
March 20, 2012
March 22, 2012
November 14, 2013
March 2012
May 2013   (Final data collection date for primary outcome measure)
Lean body mass [ Time Frame: approximately three years ]
Accessed by DXA scanning
Lean body mass [ Time Frame: approximately three years ]
Acessed by DXA scanning
Complete list of historical versions of study NCT01560546 on ClinicalTrials.gov Archive Site
  • Insulin sensitivity [ Time Frame: three years ]
    Euglycemic hyperinsulinaemic clamp
  • Regional body composition and liver fat [ Time Frame: three years ]
    DXA- and MR-scans and spect
  • Glucose and lipid oxidation [ Time Frame: three years ]
    Indirect calorimetry
  • Myostatin and satellite cells [ Time Frame: 8 years ]
    Muscle biopsy
  • Inflammation [ Time Frame: 8 years ]
    Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.
  • Physical activity [ Time Frame: three years ]
    Questionaires
  • Quality of life [ Time Frame: three years ]
    Questionaires
  • Sexual function [ Time Frame: Three years ]
    Questionaires
  • Insulin sensitivity [ Time Frame: three years ]
    Euglycemic hyperinsulinaemic clamp
  • Regional body composition and liver fat [ Time Frame: three years ]
    DXA- and MR-scans and spect
  • Glucose and lipid oxidation [ Time Frame: three years ]
    Indirecet calorimetry
  • Myostatin and satellite cells [ Time Frame: 8 years ]
    Muscle biopsy
  • Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc. [ Time Frame: 8 years ]
  • Physical activity, Quality of life, Sexual function [ Time Frame: three years ]
    Questionaires
Not Provided
Not Provided
 
Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Hypogonadism
  • Drug: Testosterone
    50 mg/dose/day for 24 weeks
    Other Name: Testim
  • Drug: Placebo
    placebo on the skin for 24 weeks
  • Active Comparator: Testim
    Intervention: Drug: Testosterone
  • Placebo Comparator: Placebo
    Placebo for 24 weeks
    Intervention: Drug: Placebo
Botha J, Velling Magnussen L, Nielsen MH, Nielsen TB, Højlund K, Andersen MS, Handberg A. Microvesicles Correlated with Components of Metabolic Syndrome in Men with Type 2 Diabetes Mellitus and Lowered Testosterone Levels But Were Unaltered by Testosterone Therapy. J Diabetes Res. 2017;2017:4257875. doi: 10.1155/2017/4257875. Epub 2017 Jan 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
November 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
50 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01560546
2011-002102-73
Yes
Not Provided
Not Provided
Marianne Andersen, Odense University Hospital
Marianne Andersen
Odense University Hospital
Principal Investigator: Marianne Andersen, MD, ph.d.
Odense University Hospital
November 2013

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