Obesity
Conditions
Interventions
Intervention Group:Personalized Medical Nutrition Therapy (MNT) combined with Liraglutide
Control Group:Nutritional and Dietary Guidance combined with Liraglutide
Sponsors
Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for obesity, with a Body Mass Index (BMI) >=28 kg/m^2. 2. Presence of Obesity-Related Complications: Diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and/or Obstructive Sleep Apnea (OSA). (1) Diagnostic Criteria for Adult MASLD: Hepatic steatosis confirmed by imaging or histology (biopsy), and presence of at least one of the following cardiometabolic risk factors: A. BMI >=23 kg/m^2, OR waist circumference >94 cm (male) / >80 cm (female), or ethnicity-specific adjustments; B. Fasting plasma glucose >=5.6 mmol/L, OR 2-hour postprandial glucose >=7.8 mmol/L, OR HbA1c >=5.7%, OR Type 2 Diabetes Mellitus (T2DM), OR currently under treatment for T2DM; C. Blood pressure >=130/85 mmHg, OR currently under specific antihypertensive drug treatment; D. Plasma triglycerides >=1.70 mmol/L, OR currently under lipid-lowering treatment; E. Plasma HDL-cholesterol = 5 events/h, with predominantly obstructive events. C. Monitoring Findings without Symptoms: Absence of the above symptoms, but PSG or PM shows an AHI >= 15 events/h, with predominantly obstructive events. 3. Aged 18-60 years. 4. Capable of signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Comorbidities such as diabetes, hyperthyroidism or hypothyroidism, adrenal-related diseases (Cushing's syndrome, adrenal cortical insufficiency, primary aldosteronism), growth hormone deficiency or excess; 2. Other causes that can lead to liver steatosis, especially alcohol consumption, with men consuming more than 30g per day and women consuming more than 20g per day; 3. Other factors that may cause liver diseases, such as viral hepatitis, autoimmune liver diseases, drug-induced liver injury, etc.; 4. Severe liver and kidney dysfunction (ALT more than 2.5 times the upper limit of normal, creatinine > 132µmmol/L); 5. Severe cardiovascular diseases, malignant tumors; 6. Accompanied by severe cognitive impairment and mental disorders; 7. Poor compliance, refusal to regular follow-up; 8. Pregnant or lactating women; 9. Other conditions determined by the researcher as not eligible for inclusion: using corticosteroids in the past 3 months (except inhalation or topical application); participating in or currently participating in other clinical trials or research projects within 3 months before enrollment; having a history of bariatric surgery; having a surgical history within 3 months before enrollment; allergic or intolerant to the components of the study product; planning to use other weight loss drugs, insulin sensitizers, metformin, dapagliflozin, etc. simultaneously.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lean body mass;Visceral Adipose Tissue (VAT);Subcutaneous adipose tissue(SAT) ;Anthropometric parameters (body weight, BMI, waist circumference, and hip circumference);Complication-related Parameters (Ultrasound Attenuation Parameter, Liver Stiffness Measurement, Neck Circumference, Apnea-Hypopnea Index, and Oxygen Saturation); | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum adipokines (adiponectin and asprosin);Hepatic and Renal Function Parameters;Glycemic Parameters;Lipid Profile; | — |
Countries
China
Contacts
Public ContactMin Wang
Xiangya Hospital Central South University
Outcome results
None listed