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NCT Number: NCT03792321

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

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.

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Key information

Conditions

Hypogonadism, Male Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Eunuchism Fatty Liver Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone Undecanoate

Drug

1000 mg i.m. every 10 weeks

Other names: Nebido

Placebo

Drug

Primary outcomes

  1. Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l

    Time frame: FPG was measured at baseline, after 12 months and after 24 months

    The primary outcome measure was change in glycemic control - fasting plasma glucose (FPG) mmol/l

  2. Effects of testosterone replacement therapy on glycemic control - glycated hemoglobin A1c (HbA1c) %

    Time frame: HbA1c was measured at baseline, after 12 months and after 24 months

    The primary outcome measure was change in glycemic control - glycated hemoglobin A1c (HbA1c) %

  3. Effects of testosterone replacement therapy on parameters of metabolic syndrome - change in HOMA-IR

    Time frame: HOMA-IR was calculated at the baseline, after 12 months and after 24 months of clinical trial.

    The primary outcome measure was change in Homeostasis model assessment of insulin resistance (HOMA-IR)

  4. Effects of testosterone replacement therapy on vascular function - change in flow mediated dilatation (FMD) %

    Time frame: FMD was measured at baseline, after 12 months and after 24 months

    The primary outcome measure was change in flow mediated dilatation (FMD) % assessed by vascular ultrasound

  5. Effects of testosterone replacement therapy on vascular morphology - intima-media thickness (IMT)

    Time frame: IMT was measured at baseline, after 12 months and after 24 months

    The primary outcome measure was change in intima-media thickness (IMT) mm assessed by vascular ultrasound

Secondary outcomes

  1. Effects of testosterone replacement therapy on non-alcoholic fatty liver disease (NAFLD)

    Time frame: Grade of NAFLD was determined at baseline and after 24 months

    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

  2. Effects of testosterone replacement therapy on bone mineral density (BMD)

    Time frame: Change in bone mineral density was measured at baseline and after 24 months

    The secondary outcome was change in bone mineral density assessed by dual-energy x-ray absorptiometry (DXA) g/cm^2

  3. Effects of testosterone replacement on total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations

    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

    The secondary outcome were changes in total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations - all in nmol/l

  4. Effects of testosterone replacement on prostate specific antigen (PSA)

    Time frame: Prostate specific antigen (PSA) was measured at baseline,3,6,12,15,18 and 24 months

    The secondary outcome was change in prostate specific antigen (PSA) ng/ml

  5. Effects of testosterone replacement on hematocrit

    Time frame: Hematocrit was measured at baseline,3,6,12,15,18 and 24 months

    The secondary outcome was change in hematocrit (Hct) %

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2

Acronym: SETH2

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Jan 3, 2019
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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