Overweight with weight-related comorbidities or Obesity
Conditions
Interventions
Multiphase modified ketogenic diet followed by limited energy balance diet group:Multiphase modified ketogenic diet followed by limited energy balance diet
Multiphase modified ketogenic diet followed by Semaglutide therapy group:Multiphase modified ketogenic diet followed by Semaglutide therapy
Sponsors
Jinshan Branch of Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age:18 years or older, up to 65 years old; Female: During the first visit, the serum pregnancy test result of fertile-aged women was negative, and they agreed to use effective and reliable contraceptive measures throughout the entire trial period; They are not breastfeeding. 2. BMI: Meets the following conditions: >=28 kg/m2, or >=24 kg/m2, and have been diagnosed with at least one weight-related comorbidity previously: (1) Hypertension: Undergoing antihypertensive drug treatment, or SBP >= 130 mmHg or DBP >=80 mmHg; (2) Dyslipidemia: Undergoing lipid-lowering treatment, or LDL-C >= 4.1 mmol/L, or TG >= 1.7 mmol/L, or HDL-C = 5.6 mmol/L, or post-meal 1-hour blood glucose >= 8.6 mmol/L, or post-meal 2-hour blood glucose >= 7.8 mmol/L, or HBA1c >= 5.7%; (4) Obstructive sleep apnea; (5) Non-alcoholic fatty liver disease (NAFLD). 3. The researcher believes that there is good motivation, ability, and willingness to follow the entire research protocol. 4. Can understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Have a self-reported change in body weight >5 kg within 3 months prior to screening; 2.History of or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed more than 1 year prior to screening); 3.History of or planned endoscopic and/or device-based treatment for obesity (e.g., mucosal ablation, gastric artery embolization, or intragastric balloon); 4.Have type 1 diabetes mellitus (T1DM) or T2DM that requires long-term treatment with hypoglycemic drugs, history of ketoacidosis, or hyperosmolar state/coma; 5.Have renal impairment measured as estimated glomerular filtration rate (eGFR) 3.0 × upper limit of normal (ULN), aspartate aminotransferase (AST) >1.5 × ULN, or total bilirubin (TB) >1.5 × ULN. Note: Subjects with NAFLD who have ALT = 160 mmHg and/or diastolic blood pressure >= 100 mmHg); 15.Have NYHA Functional Classification IV CHF or have any of the following cardiovascular conditions within 3 months prior to randomization: acute myocardial infarction (MI), cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF); 16.Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (for less than 5 years; 17.Are receiving or have received long-term (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) in the 3 months prior to screening, or have evidence of active autoimmune abnormalities (such as systemic lupus erythematosus or rheumatoid arthritis) and systemic glucocorticoid therapy has been required or is likely to be required; 18.Are receiving or have received drugs that may cause significant weight gain in the 3 months prior to screening; 19.Are receiving or have received drugs that promote weight loss in the 3 months prior to screening; 20.Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years; 21.Have any history of suicide attempts or suicidal ideation within 3 months prior to screening; 22.Are currently enrolled in any other clinical study or have participated in a clinical study and received treatment (including placebo) within the last 30 days; 23.Have a history of any other condition (such
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with 5% weight loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose;HbA1c;Scale;Waist circumference;Islet cell function;Liver function;Kidney function;Lipid profile; | — |
Countries
China
Contacts
Public ContactWu Wenjun
Jinshan Branch of Shanghai Sixth People’s Hospital
Outcome results
None listed