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

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560546
• Other study ID #: 2011-002102-73
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2012
• Last updated: November 13, 2013
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypogonadism
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Testosterone
50 mg/dose/day for 24 weeks
• Placebo
placebo on the skin for 24 weeks

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Marianne Andersen	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean body mass	Accessed by DXA scanning	approximately three years	Yes
Secondary	Insulin sensitivity	Euglycemic hyperinsulinaemic clamp	three years	No
Secondary	Regional body composition and liver fat	DXA- and MR-scans and spect	three years	Yes
Secondary	Glucose and lipid oxidation	Indirect calorimetry	three years	No
Secondary	Myostatin and satellite cells	Muscle biopsy	8 years	No
Secondary	Inflammation	Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.	8 years	No
Secondary	Physical activity	Questionaires	three years	No
Secondary	Quality of life	Questionaires	three years	No
Secondary	Sexual function	Questionaires	Three years	No