Ignite Creation Date:
2024-07-17 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489457
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-06-18
Brief Title:
The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEMAT
Brief 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
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
Detailed Description:
Men aged 18 - 65 years with type 2 diabetes on oral antidiabetic treatment body mass index above 30 kgm2 and functional hypogonadism total testosterone below 11 nmolL and at least 2 symptoms of hypogonadism are eligible to participate in the study The participants are randomized to either testosterone undecanoate 100 mg intramuscular injection once per 10-12 weeks or semaglutide subcutaneous injection once weekly titrated to 1 mg in concordance with Summary of product characteristics SmPC for 24 weeks
At the beginning of the study and after 24 weeks of treatment the researchers measured anthropometric body weight body composition endocrine total testosterone luteinizing hormone LH follicle-stimulating hormone FSH sex hormone binding globulin SHBG and metabolic parameters HbA1c 75-g oral glucose tolerance test OGTT insulin c-peptide The participants also gave sperm samples and completed self-reported hypogonadism symptom evaluation Ageing male symptoms AMS score International Index of erectile function 15 IIEF-15
At the beginning of the study and after 24 weeks of treatment the researchers measured anthropometric body weight body composition endocrine total testosterone luteinizing hormone LH follicle-stimulating hormone FSH sex hormone binding globulin SHBG and metabolic parameters HbA1c 75-g oral glucose tolerance test OGTT insulin c-peptide The participants also gave sperm samples and completed self-reported hypogonadism symptom evaluation Ageing male symptoms AMS score International Index of erectile function 15 IIEF-15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0120-26202013 | OTHER | None | None |