Obesity Obesity, diabetes, dyslipidemia, Non-alcoholic ste atohepatitis
Conditions
Interventions
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 effe
Sponsors
Kitamoto Takumi
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relevance of HbA1c changed at 12 months (%) to genotype | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactTakumi Kitamoto
Chiba University Hospital
Outcome results
None listed