hypogonadism, T2DM, prediabetes, overweight, obesity
Conditions
Interventions
Trade Name: Nebido
Product Name: Testosterone undecanoate
Product Code: G03BA03
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Testosterone undecanoate
CAS Number: 5949-44-0
Other d
Sponsors
Medical University Vienna, Gender Medicine Unit, Div. of Endocrinology, Dep of Medicine III
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • T2DM or prediabetes • male sex • HbA1c >=5,7% -9,0% • or fasting glucose >=100mg/dl or postprandial glucose>= 140mg/dl • Age >=18 -75 years • BMI>=25kg/m² • Hypogonadism assessed by laboratory testing (testosterone: two measurements below lower limit of normal total testosterone levels (=8 weeks stable dose, SGLT2 inhibitors >=3 months stable dose, DPP4 inhibitors or GLP1 agonist >= 3 months stable dose, and long acting insulin (basal insulin) >=8 weeks stable dose • able and willing to not change diet and physical activity during enrolement in study • consent and able to give informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Current testosterone treatment or testosterone replacement within the last 12 month • Serum creatinine>1,5mg/dl • Liver enzymes above 3 fold normal range • PSA>4.0µg/l • Hematocrit>50% • Known intolerance to testosterone undecanoate or any of its ingredients • Myocardial infarction within the last 12month • Stroke within the last 12 month • Untreated congestive heart disease • malignancy within the last 5 years before randomization • Prostate cancer or any suspicion thereof • Breast cancer • Liver tumor/cancer • Epilepsy • Migraine • Presence of any absolute or relative contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc. • patients on antidiabetic medication like Sulfonylurea or Glitazones. • Any other clinical condition that would jeopardize patients safety while participating in this clinical trial • Known autoimmune disease or chronic inflammatory condition • Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver cirrhosis of any etiology • Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake • History of bariatric surgery • Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight • Subjects receiving antihypertensive medication and/or thyroid hormones, the dose(s) of which have not been stable for at least 6 weeks prior to baseline • Current treatment with systemic steroids at time of informed consent. (Treatment with local and inhaled steroids is allowed) • Donation of blood (> 400 mL) during the previous 3 months prior to the screening visit or during the duration of the study • Participation in another trial with an investigational drug within 30 days prior to informed consent. • Any subject who is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol. • Contraindication for intramuscular injection (e.g patient receiving anticoagulants on a regular basis such as NOAKs or VKAs, or DAPT). • COPD Gold IV or recurrent acute or allergic asthma (for MPI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •to identify the effects of testosterone supplementation in hypogonadal men suffering from type 2 diabetes or prediabetes on intrahepatic fat content assessed as change from baseline to follow up;Secondary Objective: To identify the effects of testosterone supplementation in hypogonadal men suffering from type 2 diabetes or prediabetes on myocardial and pancreatic fat content, subcutaneous and visceral fat accumulation assessed as change from baseline to follow up, as well as on weight and body composition, glycaemic control measured as changes from baseline on HbA1c and changes from baseline on insulin secretion and sensitivity assessd by oGTT, cardiometabolic parameters (e.g. HDL,LDL, Lpa, chol, trig, usCRP, BNP, PAI1, GDF15, TNF a, IL 6, MCP1, Leptin, Adiponectin and others), RRsys, RRdia, heart rate at rest, on 24hour blood pressure measurement, on continuous glucose measurement, on carotid intima-media-thickness, on systolic and diastolic function of the heart assessed by MR techniques, on quality of life, on sexual function, on physical activity and eating behavior, on lipid distribution, on kidney function, on cardiac perfusion and cardiac performance, on bone function. ;Primary end point(s): •Change in liver fat content measured by magnetic resonance spectroscopy (MRS) from baseline to week 52;Timepoint(s) of evaluation of this end point: baseline to week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in body fat, liver volume, visceral adipose tissue, subcutaneous adipose tissue, total adipose tissue and total lean tissue, myocardial and pancreatic fat and ventricular function from baseline to week 52 • change in systolic and diastolic blood pressure from baseline to week 52 • change in body weight from baseline to week 52 • The change in waist, hip and neck circumference from baseline after 52 weeks of treatment. • The change in insulin sensitivity and Insulin secretion assessed by oGTT from baseline • change in HbA1c from baseline to week 52 • The change in lipid profile from baseline and free fatty acids in the OGTT • The occurrence of confirmed symptomatic hypoglycaemic events. • Changes in quality of live, sexual function and diabetes management satisfaction from baseline to week 52Change in cardiac parameters and cardiometabolic parameters from baseline to week 52 • Change in kidney function and relevant parameters (GFR, Alb/Krea ratio) from baseline to week 52 • Assessement of changes in controlled attenuation parameter (CAP) and transient elastography from baseline to week 52. Steatosis assessed by CAP will be used in patients not able to perform MRS ;Timepoint(s) of evaluation of this end point: baseline to week 52 | — |
Countries
Austria
Contacts
Public ContactMedical University Vienna
Medical University Vienna, Gender Medicine Unit, Div. of Endocrinology, Dep of Medicine III
Outcome results
None listed