Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Lean body mass
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Testim
Intervention: Testosterone (Drug)
Placebo
Placebo for 24 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Lean body mass
Time Frame: approximately three years
Accessed by DXA scanning
Secondary Outcomes
- Insulin sensitivity(three years)
- Regional body composition and liver fat(three years)
- Myostatin and satellite cells(8 years)
- Sexual function(Three years)
- Quality of life(three years)
- Glucose and lipid oxidation(three years)
- Physical activity(three years)
- Inflammation(8 years)
Investigators
Marianne Andersen
MD, ph.d.
Odense University Hospital