Actively Recruiting
52 Week Study of Testosterone Undecanoate vs Placebo on Liver Fat in Overweight or Obese Men with Type 2 Diabetes or Prediabetes and Low Testosterone Followed by 108 Week Open-Label Phase on Cardiometabolic Effects
Led by Alexandra Kautzky-Willer · Updated on 2024-03-13
32
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
A
Alexandra Kautzky-Willer
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the impact of testosterone undecanoate compared to a placebo on reducing liver fat in overweight or obese men who have type 2 diabetes or prediabetes along with low testosterone (hypogonadism). This condition may contribute to metabolic syndrome, cardiovascular disease, and non-alcoholic fatty liver disease (NAFLD), which are increasing worldwide and linked to insulin resistance and fat buildup in the liver. The study also explores the role of testosterone in glucose metabolism and heart health in this high-risk group. Participants receive either intramuscular injections of testosterone undecanoate (1000mg/4ml) at the start, after 6 weeks, and then every 10 weeks for a total of 52 weeks, or a similar placebo injection on the same schedule. After this 52-week randomized, quadruple-blind phase, an additional open-label extension lasting 108 weeks will follow to examine long-term effects on cardiometabolic health. The study measures changes in liver fat, visceral fat, pancreatic fat, myocardial fat, glycemic control, and cardiovascular safety. During the study, participants undergo regular assessments including body measurements, blood tests for insulin sensitivity, HbA1c, lipid levels, blood pressure, and questionnaires on quality of life, sexual function, and diabetes management satisfaction. Imaging scans evaluate fat content in various organs and heart perfusion. Safety is closely monitored throughout both study phases. Total participation may last up to three years, combining the initial treatment and the extension period.
CONDITIONS
Brief Title
Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism
Who Can Participate
Eligibility Criteria
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
- Confirmed low testosterone levels (testosterone < 4.04 ng/ml)
- Stable doses of certain diabetes medications (Metformin, SGLT2 inhibitors, DPP4 inhibitors, GLP1 RA, long-acting insulin) for specified durations
- Willingness to maintain diet and physical activity during the study
- Able to give informed consent
You will not qualify if you...
- Current or recent testosterone treatment within the last 12 months
- Serum creatinine > 1.5 mg/dl
- Liver enzymes elevated above three times the normal range
- PSA level above 4.0 µg/l
- Hematocrit above 50%
- Known allergy or intolerance to testosterone undecanoate or its ingredients
- Recent myocardial infarction or stroke within the last 12 months
- Untreated congestive heart disease
- Cancer diagnoses within specified periods (prostate, breast, liver tumors)
- Epilepsy or migraine
- Contraindications for MRI (e.g., pacemakers, metallic implants)
- Use of certain antidiabetic medications (Sulfonylurea or Glitazones)
- Autoimmune or chronic inflammatory diseases
- Other liver diseases or cirrhosis
- Alcohol or drug abuse within 3 months prior
- History of bariatric surgery or recent anti-obesity treatments
- Unstable doses of antihypertensive or thyroid medications
- Uncontrolled or untreated hypertension
- Current systemic steroid treatment
- Recent blood donation exceeding 400 mL
- Participation in other investigational drug trials within 30 days
- Staff involved in the study conduct
- Contraindications for intramuscular injections or cardiac stress tests
- Severe COPD or recurrent asthma (for specific imaging tests)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive intramuscular injections of testosterone undecanoate or placebo to study effects on liver fat and metabolic parameters.
Initial injection, followed by injections at 6 weeks and every 10 weeks thereafter
Duration - 108 weeks
Participants are observed for cardiometabolic effects during an open-label phase following the initial treatment period.
Periodic assessments during open-label follow-up
Trial Site Locations
Total: 1 location
1
Abt. für Endokrinologie & Stoffwechsel, Univ. Klin f. Innere Medizin III
Vienna, Austria, 1090
Actively Recruiting
Research Team
J
Jürgen Harreiter, PhD
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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