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

Launched by ALEXANDRA KAUTZKY-WILLER · Feb 21, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring whether a medication called Testosterone undecanoate can help reduce fat in the liver of overweight or obese men who have type 2 diabetes or prediabetes and low testosterone levels, known as hypogonadism. The study will compare the effects of testosterone treatment with a placebo (a dummy treatment) over a period of 52 weeks. Researchers aim to see if testosterone therapy can improve liver fat content, which is important because high levels of fat in the liver can lead to serious health problems.

To participate in this trial, men aged 18 to 75 with a body mass index (BMI) of 25 or higher and diagnosed with prediabetes or type 2 diabetes may be eligible. They must also have low testosterone levels confirmed by lab tests. Participants will need to maintain their current diet and exercise habits during the study. It's important to note that individuals currently receiving testosterone treatment, or those with certain serious health conditions, may not qualify. Those who join the study can expect regular check-ups and assessments to monitor their health and the effects of the treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 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
• • 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.