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Clinical Trial Details

Trial ID: L4674
Source ID: NCT03792321
Associated Drug: Testosterone Undecanoate
Title: Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)
Acronym: SETH2
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hypogonadism, Male|Diabetes Mellitus, Type 2|Obesity
Interventions: DRUG: Testosterone Undecanoate|DRUG: Placebo
Outcome Measures: Primary: Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l, The primary outcome measure was change in glycemic control - fasting plasma glucose (FPG) mmol/l, FPG was measured at baseline, after 12 months and after 24 months|Effects of testosterone replacement therapy on glycemic control - glycated hemoglobin A1c (HbA1c) %, The primary outcome measure was change in glycemic control - glycated hemoglobin A1c (HbA1c) %, HbA1c was measured at baseline, after 12 months and after 24 months|Effects of testosterone replacement therapy on parameters of metabolic syndrome - change in HOMA-IR, The primary outcome measure was change in Homeostasis model assessment of insulin resistance (HOMA-IR), HOMA-IR was calculated at the baseline, after 12 months and after 24 months of clinical trial.|Effects of testosterone replacement therapy on vascular function - change in flow mediated dilatation (FMD) %, The primary outcome measure was change in flow mediated dilatation (FMD) % assessed by vascular ultrasound, FMD was measured at baseline, after 12 months and after 24 months|Effects of testosterone replacement therapy on vascular morphology - intima-media thickness (IMT), The primary outcome measure was change in intima-media thickness (IMT) mm assessed by vascular ultrasound, IMT was measured at baseline, after 12 months and after 24 months | Secondary: Effects of testosterone replacement therapy on non-alcoholic fatty liver disease (NAFLD), The secondary outcome was change in grade of non-alcoholic fatty liver disease (NAFLD) graded as either "none", "mild", "moderate" and "severe", assessed by abdominal ultrasound, Grade of NAFLD was determined at baseline and after 24 months|Effects of testosterone replacement therapy on bone mineral density (BMD), The secondary outcome was change in bone mineral density assessed by dual-energy x-ray absorptiometry (DXA) g/cm\^2, Change in bone mineral density was measured at baseline and after 24 months|Effects of testosterone replacement on total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations, The secondary outcome were changes in total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations - all in nmol/l, Changes in total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations were measured baseline, after 12 months and 24 months|Effects of testosterone replacement on prostate specific antigen (PSA), The secondary outcome was change in prostate specific antigen (PSA) ng/ml, Prostate specific antigen (PSA) was measured at baseline,3,6,12,15,18 and 24 months|Effects of testosterone replacement on hematocrit, The secondary outcome was change in hematocrit (Hct) %, Hematocrit was measured at baseline,3,6,12,15,18 and 24 months
Sponsor/Collaborators: Sponsor: University Medical Centre Ljubljana
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 55
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-01-10
Completion Date: 2018-03-05
Results First Posted:
Last Update Posted: 2019-01-04
Locations:
URL: https://clinicaltrials.gov/show/NCT03792321