Obesity
Conditions
Interventions
After six months of standard obesity management, including dietary counseling and exercise therapy, subcutaneous administration of tirzepatide (2.5 mg once weekly) will be initiated. While monitoring
Sponsors
ASO Clinic, Director
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The target sample size across all participating institutions is 40 patients. Eligible participants will be those who meet the inclusion criteria listed below and do not meet any of the exclusion criteria. Inclusion Criteria Patients diagnosed with one or more of the following conditions-type 2 diabetes mellitus, hypertension, and/or dyslipidemia-and currently receiving pharmacological treatment. Patients who have received nutritional counseling at least once every two months for a minimum of six months, in accordance with an established treatment plan. BMI more than 35 kg/m2, or BMI more than 27 kg/m2 with two or more obesity-related health complications (see below). Obesity-Related Health Complications Impaired glucose tolerance (type 2 diabetes mellitus/impaired glucose tolerance) Dyslipidemia Hypertension Hyperuricemia/gout Coronary artery disease Cerebral infarction / transient ischemic attack Non-alcoholic fatty liver disease Menstrual disorders / female infertility Obstructive sleep apnea syndrome / obesity hypoventilation syndrome Musculoskeletal disorders (osteoarthritis / spondylosis) Obesity-related kidney disease
Exclusion criteria
Exclusion criteria: 1. Cases with obvious infection. 2. Cases of obvious chronic inflammatory diseases such as autoimmune diseases, or cases of long-term use of steroid drugs for treatment. 3. Cases diagnosed with advanced cancer. 4. Fresh case of cerebrovascular accident (within 12 weeks of onset). 5. Cases with liver dysfunction (ALT > 3 x facility upper limit). 6. Cases with complications that are judged to seriously impede the conduct of the study, such as respiratory disease, poorly controlled heart failure, or arrhythmia. 7. Cases with a history of alcoholism or drug addiction, or cases with psychosis or psychotic symptoms that make it difficult to participate in the study. 8. In other cases where the doctor in charge of the study determines that the subject is unsuitable for the safe conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of Tirzepatide on body weight in participants with obesity. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence and profile of adverse events associated with tirzepatide administration in patients with obesity 2. Effects of tirzepatide administration on body composition in patients with obesity, including the following parameters: muscle mass, skeletal muscle mass, skeletal muscle index (SMI), fat mass, body fat percentage, visceral fat level, basal metabolic rate, bone mineral content, and basal metabolic rate 3. Effects of tirzepatide administration on fingertip advanced glycation end products (AGEs) score in patients with obesity 4. Effects of tirzepatide administration on the following metabolic parameters in patients with obesity: HbA1c, fasting plasma glucose, systolic and diastolic blood pressure, lipid profile (LDL-C, HDL-C, triglycerides), estimated glomerular filtration rate (eGFR), liver function parameters (AST, ALT, GGT), FIB-4 index, fasting insulin, fasting C-peptide (CPR), HOMA-R, insulinogenic index assessed by a 75-g oral glucose tolerance test (OGTT), serum total protein, serum albumin, and changes in concomitant medications and the number of medications from baseline. | — |
Countries
Japan
Contacts
Public ContactKatsumi Aso
ASO Clinic Secretariat
Outcome results
None listed