Status:
RECRUITING
Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism
Lead Sponsor:
Alexandra Kautzky-Willer
Collaborating Sponsors:
Bayer
Conditions:
Fatty Liver
Overweight/Obesity
Eligibility:
MALE
18-75 years
Phase:
PHASE4
Brief Summary
The epidemics of obesity, MeTSy, T2DM and CVD are increasing worldwide. Non-alcoholic fatty liver disease (NAFLD) is becoming recognized as a condition possibly involved in the pathogenesis of these d...
Detailed Description
Background The epidemics of obesity, metabolic syndrome, type 2 diabetes, and atherosclerosis are increasing worldwide. Non-alcoholic fatty liver disease (NAFLD), for a long time unnoted in the metabo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Uncontrolled/ untreated hypertension
- 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.
- 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)
- Contraindications for cardiac stress test as acute myocardial infarction, instable angina, severe hypertension, myocarditis, life threatening rhythmic disorders without physical activity.
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03851627
Start Date
January 25 2022
End Date
December 1 2028
Last Update
March 13 2024
Active Locations (1)
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1
Abt. für Endokrinologie & Stoffwechsel, Univ. Klin f. Innere Medizin III
Vienna, Austria, 1090