Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism

Ki vehet részt

• prediabetes/T2DM
• 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 < 4,04ng/ml (=14nmol/l) Metformin 8 weeks stable dose, SGLT2 inhibitors 3 months stable dose, DPP4 inhibitors 3 months stable dose, GLP1 RA 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 enrollment in study
• consent and able to give informed consent

Ki nem vehet részt

• patients on antidiabetic medication like Sulfonylurea or Glitazones
• 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
• 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
• contraindication for intramuscular injection (e.g patient receiving anticoagulants on a regular basis such as NOAKs or VKAs, or DAPT)
• 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
• 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
• 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
• History of bariatric surgery
• Uncontrolled/ untreated hypertension
• COPD Gold IV or recurrent acute or allergic asthma (for MPI)
• Contraindications for cardiac stress test as acute myocardial infarction, instable angina, severe hypertension, myocarditis, life threatening rhythmic disorders without physical activity
• Serum creatinine>1,5mg/dl
• PSA>4.0μg/l
• Current testosterone treatment or testosterone replacement within the last 12 month
• Liver enzymes above 3 fold normal range
• Hematocrit>50%
• Known intolerance to testosterone undecanoate or any of its ingredients
• Migraine
• Pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol