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
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
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
NCT ID
NCT03792321
First Posted
December 27, 2018
Last Updated
January 2, 2019
Sponsor
University Medical Centre Ljubljana
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
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Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)
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