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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01560546

Enrollment

Registered

2012-03-22

Start date

2012-03-31

Completion date

2013-11-30

Last updated

2013-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism, Type 2 Diabetes Mellitus

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.

Interventions

DRUGTestosterone

50 mg/dose/day for 24 weeks

DRUGPlacebo

placebo on the skin for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

50 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Lean body mass	approximately three years	Accessed by DXA scanning

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026