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

NCT03792321 | Completed Phase 4 DMC

• 1 other identifier: SBCE-KG-2014-1
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypogonadism, Male; Diabetes Mellitus, Type 2; Obesity

Keywords

testosterone; hypogonadism; diabetes mellitus; visceral obesity; insulin resistance; metabolic syndrome; NAFLD; endothelial function

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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.

• 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

• 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 Outcomes (5)

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

  Grade of NAFLD was determined at baseline and after 24 months

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

  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

  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)

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

• Effects of testosterone replacement on hematocrit

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

Study Arms (2)

Testosterone

ACTIVE COMPARATOR

Testosterone arm patients were receiving testosterone undecanoate 1000 mg intramuscular injections two years; according to the protocol every 10 weeks

Drug: Testosterone Undecanoate

Placebo

PLACEBO COMPARATOR

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

Interventions

Testosterone Undecanoate DRUG

1000 mg i.m. every 10 weeks

Also known as: Nebido

Placebo; Testosterone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men aged \> 35 years
• body mass index \> 30 kg/m2
• confirmed hypogonadism
• type 2 diabetes mellitus treated with non-insulin therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

MeSH Terms

Conditions

Eunuchism; Diabetes Mellitus, Type 2; Obesity; Hypogonadism; Diabetes Mellitus; Obesity, Abdominal; Insulin Resistance; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Kristina Groti Antonic, MD, PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; MD, PhD, specialist in Internal medicine

Model Details: 55 patients were divided in two groups. P group patients were receiving placebo throughout the first year of this study and T group patients were receiving testosterone. Both groups were receiving TRT throughout the second year.

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 3, 2019
• Study Start: January 10, 2014
• Primary Completion: March 5, 2015
• Study Completion: March 5, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01