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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Hypogonadism
• Interventions: Drug: Testosterone; Drug: Placebo

• Registration Number: NCT01560546
• Lead Sponsor: Marianne Andersen

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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Primary Completion: 2013-05
• Status Verified: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-13
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testim	Testosterone	-
Placebo	Placebo	Placebo for 24 weeks

Primary Outcome Measures

Name	Time	Method
Lean body mass	approximately three years	Accessed by DXA scanning

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endocrinology, Odense University Hospital; 🇩🇰 Odense, Denmark