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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03792321
Other study ID # SBCE-KG-2014-1
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 10, 2014
Est. completion date March 5, 2018

Study information

Verified date January 2019
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date March 5, 2018
Est. primary completion date March 5, 2015
Accepts healthy volunteers No
Gender Male
Age group 35 Years and older
Eligibility Inclusion Criteria:

- men aged > 35 years

- body mass index > 30 kg/m2

- confirmed hypogonadism

- type 2 diabetes mellitus treated with non-insulin therapy

Exclusion Criteria:

- previously treated hypogonadism

- the 2 diabetes mellitus treated with insulin therapy

- a history of current prostate or breast cancer

- severe benign prostatic hyperplasia

- elevated prostate-specific antigen (PSA > 4.0 lg/l)

- severe heart failure

- acute coronary event or procedure during the six months leading up to the study

- chronic obstructive lung disease

- hypothyroidism

- severe obstructive sleep apnea (OSA)

- active infection

- rheumatoid arthritis

Study Design


Intervention

Drug:
Testosterone Undecanoate
1000 mg i.m. every 10 weeks
Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

Outcome

Type Measure Description Time frame Safety issue
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
Primary 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
Primary 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.
Primary 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
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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