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

Study acronym: Test2Func
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Sep 2025 to Sep 2028
    • Study completion date: Dec 2025 to Dec 2028
    v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Primary completion date: Apr 2023 to Sep 2025
    • Start date changed from estimate of Apr 2020 to Jan 25, 2022
    • Study completion date: Dec 2023 to Dec 2025
    • Eligibility criteria expanded, about 25 words
    • Site details revised
    • Study title expanded, about 2 words
  3. Start date: Apr 2019 to Apr 2020v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Alexandra Kautzky-Willer
1 trial monitored
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Diabetes
5,087 trials monitored
See 222 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
Type 2 Diabetes
2,231 trials monitored
See 111 trials at risk
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.
Trial Details
NCT Number NCT03851627
Lead Sponsor Alexandra Kautzky-Willer
Collaborators: Bayer
Conditions
(from sponsor)		 Fatty Liver, Overweight/Obesity, Prediabetes/Type2 Diabetes Mellitus, Hypogonadism, Male
Related terms Eunuchism, Fatty Liver, Obesity, Overweight, Prediabetic State
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov