Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)

Obesity Clinical Trial

— SETH2  

Official title:

Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792321
• Other study ID #: SBCE-KG-2014-1
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypogonadism
• Hypogonadism, Male
• Obesity

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