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

JRCT ID: jRCT1031230422

Registered date:24/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 24/10/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Patients with severe obesity who are undergoing lifestyle interventions such as diet and exercise will be treated with either tirzepatide or semaglutide, GLP-1-related drugs that have been proven effective for weight loss and are approved as reimbursement drugs in Japan, and observed for 12 months. Obesity-related diseases will be diagnosed at the beginning of the intervention (glucose intolerance, dyslipidemia, fatty liver, hypertension, hyperuricemia, and obesity-related kidney disease).

Outcome(s)

• Primary Outcome: Relevance of HbA1c changed at 12 months (%) to genotype

Secondary Outcome

Secondary efficacy outcomes
1) Percent weight loss at 6 and 12 months
2) Percent change in HbA1c at 6 months (%)
3) Percentage change in serum lipids at 6 and 12 months (%)
4) Percent change in systolic and diastolic blood pressure at 6 and 12 months (%)
5) Degree of improvement in health problems of o besity-related diseases at 12 months
6) Percentage of reduction of medication for healt h problems at 6 and 12 months
7) Reduction in visceral fat mass (%) at 12 months 8) Change in body fat and lean body mass at 12 m onths (%)
9) Percentage change in liver function (AST, ALT, G-GTP) at 12 months (%)
10) Change in liver hardness measured by abdominal ultrasound (VCTE)
11) Hepatocyte gene expression change at 12 mo nths
12) NAFLD activity score (NAS) change using liver biopsy histopathology
Secondary safety outcomes
Frequency of the following
1) Frequency of adverse events
2) Sudden death
3) Cardiovascular events
4) Stroke
5) Onset of malignancy
6) Onset or worsening of psychiatric disorders
7) Frequency of onset or worsening of musculoske letal disorders

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kitamoto Takumi
• Source(s) of Monetary Support: Clinical Reseach Initiation-Fund (of Chiba University Hospital)