Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-25 @ 8:50 AM
Study NCT ID:
NCT05340868
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2022-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetics of the Acute Response to Oral Semaglutide
Sponsor:
Medical University of Bialystok
Organization:
Study Overview
Official Title:
Genetics of the Acute Response to Oral Semaglutide (GAROS)
Status:
RECRUITING
Status Verified Date:
2024-11
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:
GAROS
Brief Summary:
The study aims to investigate the genetic basis of the response to short-term (3 months) orally administered semaglutide treatment, in terms of improving metabolic parameters, including the hormonal response to a standardized meal, and changes in body composition and liver steatosis. In the study, parameters such as fasting and 2-hour glucose during OGTT, HbA1c, body fat mass, body weight, total cholesterol, HDL and LDL, triglycerides, HOMA-IR, Matsuda Index and liver steatosis will be assessed. All the patients will undergo genome-wide genotyping. Moreover, in a subset of participants, muscle and fat biopsies will be performed, before and after the treatment, and liver, muscle and pancreas fat content will be assessed using MRI.
Detailed Description:
Each subject will participate in the following visits:
Visit v1 (screening) - for each patient, fasting venous blood will be collected and an oral glucose tolerance test (OGTT) will be performed - with blood samples taken 30, 60, 90 and 120 minutes after drinking the glucose solution. Fasting blood samples will be used to measure basic metabolic parameters (including glucose, lipid profile, HbA1c, AST, ALT, GGTP, electrolytes, blood count, the presence of antibodies against beta-cell antigens, TSH), and from blood collected at each time point during the OGTT glucose and insulin concentrations will be measured. Each patient will also undergo a detailed body composition analysis using bioimpedance and DXA. In addition, during the visit, each participant will receive a continuous glucose monitoring system (CGM) and an accelerometer to measure physical activity for a period of 10-14 days.
Visit v2 (14-30 days after v1)- during the visit, each patient will undergo a mixed meal tolerance test (MMTT), with blood samples taken 5, 10, 15, 30, 60, 90, 120, 180 minutes after eating the meal, along with a non-invasive measurement of resting energy expenditure (RMR). After the end of the test, the patient will receive semaglutide in two marked doses: 3 mg and 7 mg, along with instructions on how to take them and a diary in which the drug intake and occurrence of side effects will be recorded.
Visit v3 - four weeks after starting the semaglutide treatment. During the visit, fasting venous blood will be collected to measure basic metabolic parameters. Each patient will undergo a detailed body composition analysis using bioimpedance and DXA. During the visit, patients will receive semaglutide in the dose of 14 mg, along with instructions on how to take them and a diary in which the drug intake and occurrence of side effects will be recorded.
Visit v4 - twelve weeks after starting semaglutide treatment. Similar to visit 1 (OGTT).
Visit v5 - twelve weeks after starting semaglutide treatment. Similar to visit 2 (MMTT).
Visit v6 (follow-up visit) - after twelve weeks of ending the semaglutide treatment. Similar to visit 1 (OGTT).
Additionally, a random 20% of the study group will participate in additional visits:
Visit A.1 (between visits v1 and v2), A.2 (+ 1-5 days from visit v5) and A.3 (+ 1-5 days from visit v6) - during the visit, biological material will be collected for each patient in the form of a biopsy of the vastus lateralis muscle and subcutaneous adipose tissue.
Visit B.1 (between visits v1 and v2), B.2 (+ 1-5 days from visit v5) and B.3 (+ 1-5 days from visit v6)- during the visit, patients will undergo an abdominal MRI scan to assess the steatosis of the liver, muscle and pancreas.
Visit v1 (screening) - for each patient, fasting venous blood will be collected and an oral glucose tolerance test (OGTT) will be performed - with blood samples taken 30, 60, 90 and 120 minutes after drinking the glucose solution. Fasting blood samples will be used to measure basic metabolic parameters (including glucose, lipid profile, HbA1c, AST, ALT, GGTP, electrolytes, blood count, the presence of antibodies against beta-cell antigens, TSH), and from blood collected at each time point during the OGTT glucose and insulin concentrations will be measured. Each patient will also undergo a detailed body composition analysis using bioimpedance and DXA. In addition, during the visit, each participant will receive a continuous glucose monitoring system (CGM) and an accelerometer to measure physical activity for a period of 10-14 days.
Visit v2 (14-30 days after v1)- during the visit, each patient will undergo a mixed meal tolerance test (MMTT), with blood samples taken 5, 10, 15, 30, 60, 90, 120, 180 minutes after eating the meal, along with a non-invasive measurement of resting energy expenditure (RMR). After the end of the test, the patient will receive semaglutide in two marked doses: 3 mg and 7 mg, along with instructions on how to take them and a diary in which the drug intake and occurrence of side effects will be recorded.
Visit v3 - four weeks after starting the semaglutide treatment. During the visit, fasting venous blood will be collected to measure basic metabolic parameters. Each patient will undergo a detailed body composition analysis using bioimpedance and DXA. During the visit, patients will receive semaglutide in the dose of 14 mg, along with instructions on how to take them and a diary in which the drug intake and occurrence of side effects will be recorded.
Visit v4 - twelve weeks after starting semaglutide treatment. Similar to visit 1 (OGTT).
Visit v5 - twelve weeks after starting semaglutide treatment. Similar to visit 2 (MMTT).
Visit v6 (follow-up visit) - after twelve weeks of ending the semaglutide treatment. Similar to visit 1 (OGTT).
Additionally, a random 20% of the study group will participate in additional visits:
Visit A.1 (between visits v1 and v2), A.2 (+ 1-5 days from visit v5) and A.3 (+ 1-5 days from visit v6) - during the visit, biological material will be collected for each patient in the form of a biopsy of the vastus lateralis muscle and subcutaneous adipose tissue.
Visit B.1 (between visits v1 and v2), B.2 (+ 1-5 days from visit v5) and B.3 (+ 1-5 days from visit v6)- during the visit, patients will undergo an abdominal MRI scan to assess the steatosis of the liver, muscle and pancreas.
Study Oversight
Has Oversight DMC:
False
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?: