Obesity
Conditions
Interventions
Patients who require retreatment after completing semaglutide therapy and express a preference to switch to tirzepatide treatment will receive tirzepatide.
Sponsors
Aso clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with obesity who are receiving outpatient care at Aso Clinic or Kumamoto University Hospital and meet the following criteria: Patients who have been diagnosed with at least one of the following conditions and are receiving pharmacotherapy: type 2 diabetes mellitus and/or hypertension and/or dyslipidemia. Patients who have a history of nutritional counseling based on a treatment plan at least once every two months for at least six months. Patients who have not achieved sufficient effects with diet and exercise therapy and who have a BMI of >=35, or a BMI of >=27 with two or more obesity-related health disorders.* *Obesity-related health disorders: 1) Glucose intolerance, including type 2 diabetes mellitus or impaired glucose tolerance; 2) dyslipidemia; 3) hypertension; 4) hyperuricemia/gout; 5) coronary artery disease; 6) cerebral infarction/transient ischemic attack; 7) non-alcoholic fatty liver disease; 8) menstrual disorders/female infertility; 9) obstructive sleep apnea syndrome/obesity hypoventilation syndrome; 10) musculoskeletal disorders, including osteoarthritis and spondylosis deformans; and 11) 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 |
|---|---|
| Changes in body weight and waist circumference during tirzepatide treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events associated with tirzepatide treatment Effects of tirzepatide treatment on body composition, including: muscle mass, skeletal muscle mass, skeletal muscle index (SMI), body fat mass, body fat percentage, visceral fat level, basal metabolic rate, bone mineral content, and resting basal metabolic rate (optional) Effects of tirzepatide treatment on fingertip AGEs score Effects of tirzepatide treatment on the following metabolic parameters and related factors: HbA1c, fasting plasma glucose, systolic/diastolic blood pressure, lipid profile (LDL-C, HDL-C, TG), eGFR, liver function parameters (AST, ALT, GGT), FIB-4 index, fasting insulin, fasting CPR, HOMA-R, insulinogenic index based on the 75-g oral glucose tolerance test, serum total protein, serum albumin, baseline medication use, and changes in the number of medications after treatment initiation. | — |
Countries
Japan
Contacts
Public ContactKatsumi Aso
ASO Clinic Secretariat
Outcome results
None listed