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Clinical Trial Details

Trial ID: L2001
Source ID: NCT03851627
Associated Drug: Testosterone Undecanoate
Title: Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism
Acronym: Test2Func
Status: RECRUITING
Study Results: NO
Results:
Conditions: Fatty Liver|Overweight/Obesity|Prediabetes/Type2 Diabetes Mellitus|Hypogonadism, Male
Interventions: DRUG: Testosterone Undecanoate|DRUG: Placebo
Outcome Measures: Primary: Liver fat, Change in Liver fat content, baseline to week 52, and after 2 years follow up | Secondary: body weight, change in body weight, baseline to week 52, and after 2 years follow up|waist, hip and neck circumference, change in waist, hip and neck circumference, baseline to week 52, and after 2 years follow up|insulin sensitivity, change in insulin sensitivity and Insulin secretion assessed by oGTT, baseline to week 52, and after 2 years follow up|Level of HbA1c, change in HbA1c from baseline to week 52, baseline to week 52, and after 2 years follow up|Concentration of lipids, change in lipid profile from baseline and free fatty acids in the OGTT, baseline to week 52, and after 2 years follow up|quality of live questionnaire, change of quality of live assessed by WHO 5 Well Being Questionnaire, baseline to week 52, and after 2 years follow up|blood pressure, change in systolic and diastolic blood pressure, baseline to week 52, and after 2 years follow up|sexual function questionnaire, change sexual function assessed by International Index of Erectile Dysfunction questionnaire, baseline to week 52, and after 2 years follow up|diabetes management satisfaction questionnaire, change of diabetes management satisfaction assessed by Diabetes Treatment Satisfaction Questionnaire, baseline to week 52, and after 2 years follow up | Other: amount of body fat, Change in body fat, liver volume, visceral adipose tissue, subcutaneous adipose tissue, total adipose tissue and total lean tissue, myocardial and pancreatic fat and ventricular function, baseline to week 52, and after 2 years follow up|level of HbA1c, The occurrence of treat to target efficacy i.e. HbA1c \< 7.0 % or \< 6.5 %., baseline to week 52, and after 2 years follow up|HbA1c reduction >=0.5%, The occurrence of a relative efficacy response. i.e. HbA1c lowering of at least 0.5%, baseline to week 52, and after 2 years follow up|mean daily glucose profile, The change from baseline in mean daily glucose profile assessed by 8 point glucose profiles, baseline to week 52, and after 2 years follow up|weight, The change in weight (\>5% and \>10%), baseline to week 52, and after 2 years follow up|IMT, Change in Intima Media Thickness, baseline to week 52, and after 2 years follow up|Albumin/ Creatinine Ratio, Change in Albumin/ Creatinine Ratio, baseline to week 52, and after 2 years follow up|myocardial flow reserve, Change in myocardial flow reserve, baseline to week 52, and after 2 years follow up|concentration of osteocalcin, Change in concentration of osteocalcin, baseline to week 52, and after 2 years follow up|amount of visceral adipose tissue,, Change in amount of visceral adipose tissue,, baseline to week 52, and after 2 years follow up|amount of subcutaneous adipose tissue,, change in amount of subcutaneous adipose tissue,, baseline to week 52, and after 2 years follow up|amount of total lean tissue,, change in amount of total lean tissue,, baseline to week 52, and after 2 years follow up|amount of myocardial fat, change in amount of myocardial fat, baseline to week 52, and after 2 years follow up|amount of pancreatic fat, change in amount of myocardial fat, baseline to week 52, and after 2 years follow up
Sponsor/Collaborators: Sponsor: Alexandra Kautzky-Willer | Collaborators: Bayer
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-01-25
Completion Date: 2028-12
Results First Posted:
Last Update Posted: 2024-03-13
Locations: Abt. für Endokrinologie & Stoffwechsel, Univ. Klin f. Innere Medizin III, Wien, 1090, Austria
URL: https://clinicaltrials.gov/show/NCT03851627