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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-10

Study Completion Date

2018-03-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypogonadism, Male Diabetes Mellitus, Type 2 Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Testosterone

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

Group Type ACTIVE_COMPARATOR

Testosterone Undecanoate

Intervention Type DRUG

1000 mg i.m. every 10 weeks

Placebo

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

Group Type PLACEBO_COMPARATOR

Testosterone Undecanoate

Intervention Type DRUG

1000 mg i.m. every 10 weeks

Placebo

Intervention Type DRUG

Interventions

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Testosterone Undecanoate

1000 mg i.m. every 10 weeks

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Nebido

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No