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

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ClinicalTrials.gov Identifier: NCT03792321
Recruitment Status : Completed
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Kristina Groti, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Hypogonadism, Male Diabetes Mellitus, Type 2 Obesity Drug: Testosterone Undecanoate Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2
Actual Study Start Date : January 10, 2014
Actual Primary Completion Date : March 5, 2015
Actual Study Completion Date : March 5, 2018


Arm Intervention/treatment
Active Comparator: Testosterone
Testosterone arm patients were receiving testosterone undecanoate 1000 mg intramuscular injections two years; according to the protocol every 10 weeks
Drug: Testosterone Undecanoate
1000 mg i.m. every 10 weeks
Other Name: Nebido

Placebo Comparator: Placebo
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
1000 mg i.m. every 10 weeks
Other Name: Nebido

Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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) %



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792321


Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Kristina Groti Antonic, MD, PhD University Medical Centre Ljubljana

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Responsible Party: Kristina Groti, Principal Investigator; MD, PhD, specialist in Internal medicine, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03792321     History of Changes
Other Study ID Numbers: SBCE-KG-2014-1
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Kristina Groti, University Medical Centre Ljubljana:
testosterone
hypogonadism
diabetes mellitus
visceral obesity
insulin resistance
metabolic syndrome
NAFLD
endothelial function
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypogonadism
Eunuchism
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gonadal Disorders
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents