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

Primary Purpose

Hypogonadism, Male, Diabetes Mellitus, Type 2, Obesity

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Testosterone Undecanoate
Placebo
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism, Male focused on measuring testosterone, hypogonadism, diabetes mellitus, visceral obesity, insulin resistance, metabolic syndrome, NAFLD, endothelial function

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Testosterone

    Placebo

    Arm Description

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

    Placebo arm patients were receiving placebo throughout the first year of this study and testosterone undecanoate 1000 mg intramuscular injections during second year.

    Outcomes

    Primary Outcome Measures

    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
    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) %
    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)
    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
    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

    Secondary Outcome Measures

    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
    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
    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
    Effects of testosterone replacement on prostate specific antigen (PSA)
    The secondary outcome was change in prostate specific antigen (PSA) ng/ml
    Effects of testosterone replacement on hematocrit
    The secondary outcome was change in hematocrit (Hct) %

    Full Information

    First Posted
    December 27, 2018
    Last Updated
    January 2, 2019
    Sponsor
    University Medical Centre Ljubljana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03792321
    Brief Title
    Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)
    Acronym
    SETH2
    Official Title
    Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2014 (Actual)
    Primary Completion Date
    March 5, 2015 (Actual)
    Study Completion Date
    March 5, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Centre Ljubljana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypogonadism, Male, Diabetes Mellitus, Type 2, Obesity
    Keywords
    testosterone, hypogonadism, diabetes mellitus, visceral obesity, insulin resistance, metabolic syndrome, NAFLD, endothelial function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Testosterone
    Arm Type
    Active Comparator
    Arm Description
    Testosterone arm patients were receiving testosterone undecanoate 1000 mg intramuscular injections two years; according to the protocol every 10 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo arm patients were receiving placebo throughout the first year of this study and testosterone undecanoate 1000 mg intramuscular injections during second year.
    Intervention Type
    Drug
    Intervention Name(s)
    Testosterone Undecanoate
    Other Intervention Name(s)
    Nebido
    Intervention Description
    1000 mg i.m. every 10 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l
    Description
    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
    Title
    Effects of testosterone replacement therapy on glycemic control - glycated hemoglobin A1c (HbA1c) %
    Description
    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
    Title
    Effects of testosterone replacement therapy on parameters of metabolic syndrome - change in HOMA-IR
    Description
    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.
    Title
    Effects of testosterone replacement therapy on vascular function - change in flow mediated dilatation (FMD) %
    Description
    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
    Title
    Effects of testosterone replacement therapy on vascular morphology - intima-media thickness (IMT)
    Description
    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 Outcome Measure Information:
    Title
    Effects of testosterone replacement therapy on non-alcoholic fatty liver disease (NAFLD)
    Description
    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
    Time Frame
    Grade of NAFLD was determined at baseline and after 24 months
    Title
    Effects of testosterone replacement therapy on bone mineral density (BMD)
    Description
    The secondary outcome was change in bone mineral density assessed by dual-energy x-ray absorptiometry (DXA) g/cm^2
    Time Frame
    Change in bone mineral density was measured at baseline and after 24 months
    Title
    Effects of testosterone replacement on total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations
    Description
    The secondary outcome were changes in total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations - all in nmol/l
    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
    Title
    Effects of testosterone replacement on prostate specific antigen (PSA)
    Description
    The secondary outcome was change in prostate specific antigen (PSA) ng/ml
    Time Frame
    Prostate specific antigen (PSA) was measured at baseline,3,6,12,15,18 and 24 months
    Title
    Effects of testosterone replacement on hematocrit
    Description
    The secondary outcome was change in hematocrit (Hct) %
    Time Frame
    Hematocrit was measured at baseline,3,6,12,15,18 and 24 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kristina Groti Antonic, MD, PhD
    Organizational Affiliation
    University Medical Centre Ljubljana
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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