The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity
NCT Number: NCT06489457
Acronym: SEMAT
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Type 2 Diabetes Mellitus|Obesity|Functional Hypogonadism
Interventions: DRUG: Semaglutide|DRUG: Testosterone Undecanoate
Sponsor: University Medical Centre Ljubljana
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-09-20
Completion Date: 2023-06-30
Locations: University Medical Centre Ljubljana, Ljubljana, 1000, Slovenia

Summary:
The goal of this study is to learn whether semaglutide (treatment for type 2 diabetes and obesity) can improve signs and symptoms of hypogonadism in men with type 2 diabetes, obesity and hypogonadism (a condition when levels of testosterone are decreased).

The main questions the study aims to answer are:

* Does semaglutide improve the quality of sperm?
* Does semaglutide improve symptoms of hypogonadism as well as testosterone replacement?

The researchers will compare semaglutide to testosterone replacement to see which drug better treats symptoms of hypogonadism.

* The participants will receive testosterone replacement therapy (intramuscular injection every 10-12 weeks) or magnitude (subcutaneous injection once a week).
* The treatment will last 24 weeks.
* The participants will visit the clinic at the start and the end of the study.

At the visit, the researchers will measure body weight and take a few blood samples. The participants will also be asked to complete several questionnaires and collect a sperm sample.

The participants are free to terminate their participation in the study at any time without giving a reason.

Primary Outcome Measures: Change in semen volume from baseline and between the treatment arms, The semen volume will be measured and reported in mililiters (mL). The higher the value the better the outcome., Baseline and 24 weeks|Change in sperm concentration from baseline and between the treatment arms, The sperm concentration will be measured and reported in number times 10\^6 per mililiter (10\^6/mL). The higher the value the better the outcome., Baseline and 24 weeks|Change in total motility of sperm from baseline and between the treatment arms, The total motility will be assessed as total number of motile sperm and reported as number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome., Baseline and 24 weeks|Change in normal sperm forms from baseline and between the treatment arms, The normal sperm forms will be assessed as total number of sperm with normal morphology and reported as number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome., Baseline and 24 weeks|Change in total number of sperm from baseline and between the treatment arms, The total number of sperm will be measured and reported in number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome., Baseline and 24 weeks
Secondary Outcome Measures: Change in International index of erectile function 15 (IIEF-15) score from baseline and between the treatment arms, IIEF-15 assesses male sexual function. It has 5 domains. Erectile function with scoring range from 30 (max) to 1 (min). Orgasmic function with scoring range from 10 (max) to 1 (min). Sexual desire with scoring range from 10 (max) to 2 (min). Intercourse satisfaction with scoring range from 15 (max) to 0 (min). Overall satisfaction with scoring range from 10 (max) to 2 (min). The subdomains combine to overall score with scoring range from 75 (max) to 6 (min). The higher score indicates the better sexual function., Baseline and 24 weeks|Change in Aging male symptoms (AMS) score from baseline and between the treatment arms, The AMS score assesses male symptoms os hypogonadism. It has 3 subdomains. Psychological symptoms with scoring range from 25 (max) to 5 (min). Somatic with scoring range from 35 (max) to 7 (min). Sexual with scoring range from 25 (max) to 5 (min). The subdomains combine to overall score with scoring range from 85 (max) to 17 (min). The lower the score the less symptoms are present., Baseline and 24 weeks|Change in HbA1c from baseline and between the treatment arms, The HbA1c will be measured and reported in % and milimoles per mole (mmol/mol). The lower the value the better the outcome., Baseline and 24 weeks|Change in follicle-stimulating hormone (FSH) from baseline and between the treatment arms, The FSH will be measured and reported in international units per liter (IU/L). The higher the value the better the outcome., Baseline and 24 weeks|Change in luteinizing hormone (LH) from baseline and between the treatment arms, The LH will be measured and reported in international units per liter (IU/L). The higher the value the better the outcome., Baseline and 24 weeks|Change in estimated visceral adipose tissue from baseline and between the treatment arms, Measured by dual-energy X-ray absorptiometry the estimated visceral adipose tissue will be reported in grams (g). The lower the value the better the outcome., Baseline and 24 weeks|Change in percentage of body fat from baseline and between the treatment arms, Measured by dual-energy X-ray absorptiometry the procentage of body fat will be reported in %. The lower the value the better the outcome., Baseline and 24 weeks|Change in fasting serum low-density lipoproteins (LDL) cholesterol from baseline and between the treatment arms, The LDL cholesterol will be measured and reported in milimoles per liter (mmol/L). The lower the value the better the outcome., Baseline and 24 weeks|Change in fasting serum total cholesterol from baseline and between the treatment arms, The total cholesterol will be measured and reported in milimoles per liter (mmol/L). The lower the value the better the outcome., Baseline and 24 weeks|Change in fasting serum high-density lipoproteins (HDL) cholesterol from baseline and between the treatment arms, The HDL cholesterol will be measured and reported in milimoles per liter (mmol/L). The higher the value the better the outcome., Baseline and 24 weeks|Change in fasting triglycerides from baseline and between the treatment arms, Triglycerides will be measured and reported in milimoles per liter (mmol/L). The lower the value the better the outcome., Baseline and 24 weeks
Other Outcome Measures: Change in body mass from baseline and between the treatment arms, The body mass will be assessed and reported in kilograms (kg). The lower the value the better the outcome., Baseline and 24 weeks|Change in body mass index (BMI) from baseline and between the treatment arms, The BMI will be calculated from body mass and height using the following equation: BMI=body mass in kilograms (kg) divided by height in meters (m) squared, and reported in kg/m\^2. The lower the value the better the outcome., Baseline and 24 weeks|Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) score from baseline and between the treatment arms, The HOMA-IR will be calculated using the following equation: HOMA-IR = (fasting plasma insulin×fasting plasma glucose)/22.5. The lower the value the better the outcome., Baseline and 24 weeks