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

University Medical Centre Ljubljana55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypogonadism, Male Diabetes Mellitus, Type 2 Obesity

Interventions

Testosterone UndecanoateDRUG

1000 mg i.m. every 10 weeks

PlaceboDRUG

Eligibility

Sex: MALEMin age: 35 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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