Type 2 diabetes mellitus (T2DM) is a common endocrine disorder caracterized by hyperinsulinaemia and insulin resistance. We aim to investigate if testosterone therapy can improve body composition, insulin sensitivity, lipid metabolism and quality of life in men with low to normal bioavailable testosterone levels (<7.3 nmol/l) and T2DM. MedDRA version: 14.1 Level: LLT Classification code 10043368 Term: Testosterone decreased System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Lev
Conditions
Interventions
Trade Name: Testim®
Product Name: Testim®
Product Code: 36437
Pharmaceutical Form: Gel
INN or Proposed INN: TESTOSTERONE
CAS Number: 58-22-0
Current Sponsor code: G03B A03
Other descriptive name: 17-B
Sponsors
Endokrinologisk afd. M
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: All participating patients have to give a spoken and written informed consent. 1) Man 50-70 years of age 2) Type 2 DM diagnosed within the last 10 years 3) Metformin treated type 2 DM >= 3 months 4) Bioavailable testosterone levels =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: HbA1c = 9,0 %, BMI = 40 kg/m2, Hæmatokrit > 50%, Known malignant disease, PSA > 3 ug/L, Nykturi > 3 times, Abnormal rutine blodsamples, Severe hypertension, Significant EKG-changes, Wish of parenthood, Active mental illness, present or former abuse within one year, Severe ilness of heart-, lung- or kidney, Primary or secondary hypogonadisme.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to investigate if treatment with testosterone in men with low to normal bioavailable testosterone levels (<7.3 nmol/l) and T2DM will increase lean body mass;Secondary Objective: To investigate if treatment with testosterone in men with low to normal bioavailable testosterone levels (<7.3 nmol/l) and T2DM will 1) increase insulinsensitivity 2) reduce lipide in the liver 3) increase adiponectin-level og decrease CRP-level. 4) improve quality of life and increase physical activity 5) increase number of satellitecells in muscles;Primary end point(s): Lean body mass (LBM);Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Insulin sensitivity (Euglycemic hyperinsulinaemic clamp) Regional body composition and liver fat (DXA- and MR-scans and spect) Glucose and lipid oxidation (Indirecet calorimetry) Myostatin and satellite cells (Muscle biopsy) Hormones: Adiponectin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc. Other blood samples: Lipids Muscle power (Power Rig) Physical activity (Accelerometer) Quality of life (Questionaires) Sexual function (Questionaires) Vessel stiffness (pulse wave velocity and intima-media thickness) Safety parameters: PSA, Hb, hematocrit;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Denmark
Contacts
Public ContactDepartment of Enodocrinology
Odense University Hospital
Outcome results
None listed