Clinical trial NCT03792321: Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)
Official title: Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadism, Male
Diabetes Mellitus, Type 2
Obesity
Keywords: testosterone
hypogonadism
diabetes mellitus
visceral obesity
insulin resistance
metabolic syndrome
NAFLD
endothelial function
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 55
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l
timeFrame: FPG was measured at baseline, after 12 months and after 24 months
measure: Effects of testosterone replacement therapy on glycemic control - glycated hemoglobin A1c (HbA1c) %
timeFrame: HbA1c was measured at baseline, after 12 months and after 24 months
measure: Effects of testosterone replacement therapy on parameters of metabolic syndrome - change in HOMA-IR
timeFrame: HOMA-IR was calculated at the baseline, after 12 months and after 24 months of clinical trial.
measure: Effects of testosterone replacement therapy on vascular function - change in flow mediated dilatation (FMD) %
timeFrame: FMD was measured at baseline, after 12 months and after 24 months
measure: Effects of testosterone replacement therapy on vascular morphology - intima-media thickness (IMT)
timeFrame: IMT was measured at baseline, after 12 months and after 24 months
Secondary outcomes:
measure: Effects of testosterone replacement therapy on non-alcoholic fatty liver disease (NAFLD)
timeFrame: Grade of NAFLD was determined at baseline and after 24 months
measure: Effects of testosterone replacement therapy on bone mineral density (BMD)
timeFrame: Change in bone mineral density was measured at baseline and after 24 months
measure: Effects of testosterone replacement on total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations
timeFrame: Changes in total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations were measured baseline, after 12 months and 24 months
measure: Effects of testosterone replacement on prostate specific antigen (PSA)
timeFrame: Prostate specific antigen (PSA) was measured at baseline,3,6,12,15,18 and 24 months
measure: Effects of testosterone replacement on hematocrit
timeFrame: Hematocrit was measured at baseline,3,6,12,15,18 and 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Centre Ljubljana
name: Kristina Groti Antonic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: