Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism
Recruiting
Phase 4
Interventional Study
Fatty Liver
Overweight/Obesity
Prediabetes/Type2 Diabetes Mellitus
Hypogonadism, Male
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Male
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 32 (estimated)
- Sponsor
- Alexandra Kautzky-Willer · Other
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About This Trial
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 lipi…
Trial Locations
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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 …
Contacts