Testosterone Undecanoate's effects on liver fat in overweight men with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of Testosterone Undecanoate compared to a placebo on intrahepatic fat content in overweight or obese men diagnosed with type 2 diabetes mellitus (T2DM) or prediabetes and hypogonadism. The study aims to explore the relationship between testosterone levels and non-alcoholic fatty liver disease (NAFLD), which is increasingly recognized as a significant health issue linked to obesity and metabolic disorders. Participants will be monitored for changes in liver fat content while maintaining their usual diet and physical activity throughout the trial. The study is designed to assess whether testosterone replacement can improve liver health and metabolic outcomes in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Abt. für Endokrinologie & Stoffwechsel, Univ. Klin f. Innere Medizin III
  Vienna, Austria Recruiting

Study contacts

• Principal investigator: Alexandra Kautzky-Willer, MD — Medical University of Vienna
• Study coordinator: Jürgen Harreiter, PhD
• Email: juergen.harreiter@meduniwien.ac.at
• Phone: +43 1 40400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.