A Phase 4 interventional study of Testosterone Undecanoate and Placebo in Hypogonadism, Male, Diabetes Mellitus, Type 2 and Obesity, sponsored by University Medical Centre Ljubljana. Completed. Open to male participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by University Medical Centre Ljubljana · Phase 4, Interventional, and Treatment
Aim of the study was to investigate the effects of testosterone replacement therapy on components of metabolic syndrome, vascular function and morphology, grade of non-alcoholic fatty liver disease (NAFLD), bone mineral density (BMD) and health-related quality of life.
Studies have shown that approximately 50 % of older obese males, who are being treated for diabetes mellitus type 2, also exhibit low testosterone levels. Hypogonadism negatively affects glycemic control, exacerbates early cardio-vascular disease, causes osteoporosis, erectile disfunction, reduces lean body mass, accelerates the accumulation of visceral fat and leads to obesity.
Patients with diabetes mellitus type 2 and confirmed hypogonadism were enrolled into this randomized, double-blind, placebo-controlled clinical study. Placebo group patients were receiving placebo throughout the first year of this study and Testosterone group patients were receiving testosterone undecanoate during first year. Both groups were receiving testosterone undecanoate throughout the second year of this study.
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's enrollment of 55 is close to the median of 60 across 55 interventional studies indexed under Eunuchism.
Browse Eunuchism studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Testosterone arm patients were receiving testosterone undecanoate 1000 mg intramuscular injections two years; according to the protocol every 10 weeks
Drug: Testosterone Undecanoate
Placebo arm patients were receiving placebo throughout the first year of this study and testosterone undecanoate 1000 mg intramuscular injections during second year.
Drug: Testosterone Undecanoate · Drug: Placebo
1000 mg i.m. every 10 weeks
Also known as: Nebido
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
Time frame: 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) %
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: IMT was measured at baseline, after 12 months and after 24 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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) %
Time frame: Hematocrit was measured at baseline,3,6,12,15,18 and 24 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone undecanoate
University Medical Centre Ljubljana →