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

Phase 2

Recruiting

• Conditions: Obesity; Obesity, diabetes, dyslipidemia, Non-alcoholic ste atohepatitis; D009765

• Registration Number: JPRN-jRCT1031230422
• Lead Sponsor: Kitamoto Takumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-24
• Last Update Posted: 20 November 2023

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
3) Patients with severe diabetes mellitus with an H bA1c of 10% or higher
4)Patients with severe hypertension (systolic blood pressure > 180 mmHg)
5) Patients with severe cardiopulmonary, renal, or hepatic dysfunction that is not an indication for exercise therapy
6) Patients with serious musculoskeletal disorders that are not indications for exercise therapy
7) Patients with psychiatric disorders that are difficult to manage
8) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating
9) Patients who are unable to obtain written consent or who do not understand the outline or purpose of the study
10) 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: Not specified

Primary Outcome Measures

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