Clinical study to clarify the effect of GLP-1 on metabolic improvement bas ed on genetic background

Recruiting

• Conditions: Obesity

• Registration Number: jRCT1031230422

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-24
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Obese patients with a BMI of 30.0 kg/m2 or higher who have glucose intolerance, dyslipidemia, and fatty liver disease, as defined by the Japan Society for the Study of Obesity
2. Patients who are at least 18 years old and less than 75 years old at the time of consent
3. Patients who have been fully informed of the study and who have given written consent of their own free will after sufficient understanding of the study

Exclusion Criteria

Persons who meet any of the following conditions are not eligible

1. Secondary obesity (symptomatic obesity) 2)Patients with a history of wasting disease or condition (severe infection, invasive surgery, malignancy, severe trauma, hyperthyroidism, etc.) that causes extreme weight loss within the past 6 months from the date of consent
2. Patients with severe diabetes mellitus with an H bA1c of 10% or higher 4)Patients with severe hypertension (systolic blood pressure > 180 mmHg)
3. Patients with severe cardiopulmonary, renal, or hepatic dysfunction that is not an indication for exercise therapy
4. Patients with serious musculoskeletal disorders that are not indications for exercise therapy
5. Patients with psychiatric disorders that are difficult to manage
6. Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating
7. Patients who are unable to obtain written consent or who do not understand the outline or purpose of the study
8. Other patients who are deemed by the investigator or sub investigator to be unsuitable for the safe conduct of the study

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Relevance of HbA1c changed at 12 months (%) to genotype

Secondary Outcome Measures

Name	Time	Method
Reduction in visceral fat mass	12 months	Reduction in visceral fat mass (%) at 12 months
Change in body fat and lean body mass	12 months	Change in body fat and lean body mass at 12 months (%)
Percentage change in liver function (AST, ALT, G-GTP)	12 months	Percentage change in liver function (AST, ALT, G-GTP) at 12 months (%)
Degree of improvement in health problems of obesity-related diseases	12 months	Degree of improvement in health problems of obesity-related diseases at 12 months
Percentage of reduction of medication for health problems	6 and 12 months	Percentage of reduction of medication for health problems at 6 and 12 months
Change in liver hardness measured by abdominal ultrasound (VCTE)		Change in liver hardness measured by abdominal ultrasound (VCTE)
Percent change in systolic and diastolic blood pressure	6 and 12 months	Percent change in systolic and diastolic blood pressure at 6 and 12 months (%)
Percent weight loss	6 and 12 months	Percent weight loss at 6 and 12 months
Percent change in HbA1c	6 months	Percent change in HbA1c at 6 months (%)
Percentage change in serum lipids	6 and 12 months	Percentage change in serum lipids at 6 and 12 months (%)
Hepatocyte gene expression change	12 months	Hepatocyte gene expression change at 12 months
NAFLD activity score (NAS) change using liver biopsy histopathology		NAFLD activity score (NAS) change using liver biopsy histopathology
Frequency of adverse events		Frequency of adverse events
Sudden death		Sudden death
Cardiovascular events		Cardiovascular events
Stroke		Stroke
Onset of malignancy		Onset of malignancy
Onset or worsening of psychiatric disorders		Onset or worsening of psychiatric disorders
Frequency of onset or worsening of musculoskeletal disorders		Frequency of onset or worsening of musculoskeletal disorders