Actively Recruiting

Phase 4
Age: 18Years - 75Years
MALE
NCT03851627

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

Led by Alexandra Kautzky-Willer · Updated on 2024-03-13

32

Participants Needed

1

Research Sites

357 weeks

Total Duration

On this page

Sponsors

A

Alexandra Kautzky-Willer

Lead Sponsor

B

Bayer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 diseases. The prevailing hypothesis for NAFLD pathogenesis is the 'two-hit' model, with insulin resistance and hyperinsulinemia playing essential roles, which have a plethora of effects on hepatic lipid metabolism and can lead to accumulation of triglycerides in hepatocytes. Accepted treatment for NAFLD is lifestyle modifications. Sex hormones might be relevant in T2DM development and treatment. Low testosterone (T) has deteriorating effects on glucose levels, and aggravates in obesity as aromatization of T is enhanced. T deficiency is related to increases of visceral fat accumulation and associated with development of NAFLD. T replacement might be a successful way in hypogonadism to treat obesity and counteract progression of MEtSy,T2DM or CVD driven by visceral fat accumulation or NAFLD. Primary Objective To investigate the effects on hepatic lipid content reduction of a therapy with Testosterone undecanoate 1000mg compared to placebo given for 52 weeks in patients with type 2 diabetes mellitus and hypogonadism.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male sex
  • Age between 18 and 75 years
  • Diagnosed with prediabetes or type 2 diabetes mellitus
  • HbA1c between 5.7% and 9.0%, or fasting glucose ≥100 mg/dl, or postprandial glucose ≥140 mg/dl
  • Body mass index (BMI) of 25 kg/m² or higher
  • Laboratory confirmed hypogonadism (testosterone <4.04 ng/ml)
  • Stable dose of metformin for at least 8 weeks if used
  • Stable dose of SGLT2 inhibitors, DPP4 inhibitors, or GLP1 receptor agonists for at least 3 months if used
  • Stable dose of long-acting basal insulin for at least 8 weeks if used
  • Willing and able to maintain current diet and physical activity during the study
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Current testosterone treatment or testosterone replacement within the last 12 months
  • Serum creatinine greater than 1.5 mg/dl
  • Liver enzymes above three times the normal range
  • Prostate-specific antigen (PSA) above 4.0 µg/l
  • Hematocrit above 50%
  • Known intolerance to testosterone undecanoate or its ingredients
  • Myocardial infarction within the last 12 months
  • Stroke within the last 12 months
  • Untreated congestive heart disease
  • Malignancy within the last 5 years before randomization
  • Prostate cancer or suspicion of it
  • Breast cancer
  • Liver tumor or cancer
  • Epilepsy
  • Migraine
  • Contraindications to MRI such as pacemakers, metal implants, or active electronic devices
  • Use of sulfonylurea or glitazones antidiabetic medications
  • Any condition that would risk patient safety during the trial
  • Known autoimmune or chronic inflammatory diseases
  • Other liver diseases including chronic viral hepatitis, alcohol abuse, hemochromatosis, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis, primary biliary cirrhosis, or liver cirrhosis
  • Alcohol or drug abuse within 3 months prior to consent
  • History of bariatric surgery
  • Use of anti-obesity drugs or unstable body weight due to treatment or surgery
  • Unstable doses of antihypertensive or thyroid medications within 6 weeks prior to baseline
  • Uncontrolled or untreated hypertension
  • Current systemic steroid treatment
  • Blood donation exceeding 400 mL within 3 months prior or during study
  • Participation in another investigational drug trial within 30 days
  • Staff involved in study conduct
  • Contraindication to intramuscular injection such as regular anticoagulant use
  • Severe COPD or recurrent acute/allergic asthma
  • Contraindications for cardiac stress testing like recent heart attack or unstable angina, severe hypertension, myocarditis, or life-threatening arrhythmias without physical activity involvement

AI-Screening

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Trial Site Locations

Total: 1 location

1

Abt. für Endokrinologie & Stoffwechsel, Univ. Klin f. Innere Medizin III

Vienna, Austria, 1090

Actively Recruiting

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Research Team

J

Jürgen Harreiter, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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