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

NCT03851627 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-03-13

No results posted yet for this study

Summary

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

  • Fatty Liver
  • Overweight/Obesity
  • Prediabetes/Type2 Diabetes Mellitus
  • Hypogonadism, Male

Interventions

DRUG

Testosterone Undecanoate

1000mg/4ml i.m. initial, after 6 weeks, every 10 weeks thereafter

DRUG

Placebo

Placebo Arm

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Alexandra Kautzky-Willer

    lead OTHER

Principal Investigators

  • Alexandra Kautzky-Willer, MD · Medical University Vienna

  • Jürgen Harreiter, PhD · Medical University Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2028-09-30
Completion
2028-12-31

Countries

  • Austria

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03851627 on ClinicalTrials.gov