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Multimodal Weight Loss Intervention Cohort Study: Exploration of Metabolic Effects and Mechanisms (METABOLITE-COHORT)

Multimodal Weight Loss Intervention Cohort Study: Exploration of Metabolic Effects and Mechanisms (METABOLITE-COHORT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118823
Enrollment
Unknown
Registered
2026-02-11
Start date
2026-02-13
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Diet Group:Limit your diet to 1500 kcal/d (25% protein, 30% fat, 45% carbohydrates) or follow a ketogenic diet for one month for monitoring
Sports Group:Moderate-intensity prescription exercise: 5 days a week, 30 minutes per day for 1 month. Real-time monitoring by smart bracelet + check-in monitoring
Weight-loss drugs group:Tirzepatide subcutaneous injection starts at 2.5 mg/w, titrated to 10 mg/w, one-month electronic medication diary. Pharmacological interventions are tailored to the specific dr
Wiring assembly:The operation video of acupoint embedding once every two weeks for one month should be archived
Acupuncture Group:Electroacupuncture treatment was administered once a week for one month, the same as the suture group
Weight loss tea set:Take 2 packs of formula tea every day for 1 month. Count the tea bags and monitor the check-in video
Gastric bypass stent group:Archived records of single intervention surgeries for endoscopic implantation of absorbable stents
Surgical Group:Single intervention for sleeve gastrectomy laparoscopic surgery or robotic surgery shall be carried out in accordance with the ‘‘Surgical Guidelines for Obesity’’

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Intervention group: 1. Aged 18-60 years, BMI>=24 kg/m^2; 2. Or for men: Waist circumference >= 90 cm; for women: waist circumference >= 85 cm; 3. Meet the medical application criteria for at least one intervention method (for example, the surgical group needs to comply with the ICD guidelines); 4. Voluntarily sign the informed consent form. Control group: 1. Aged 18 to 60 years old, BMI: 18.5 <= BMI < 24kg/m^2; 2. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Secondary obesity (e.g., Cushing's syndrome, hypothalamic obesity, etc.); 2. Severe cardiovascular diseases (NYHA Class III–IV, myocardial infarction/stroke within the past 6 months); 3. Uncontrolled hypertension (SBP >= 180 mmHg or DBP >= 110 mmHg); 4. Hepatic or renal insufficiency; 5. Contraindications to bariatric surgery (ASA Class IV, coagulation disorders); 6. Pregnancy or planned pregnancy; 7. Conditions deemed by the investigator as requiring exclusion; 8. Diseases unsuitable for dietary or exercise interventions, such as cardiac diseases or bone/joint disorders; 9. Diseases unsuitable for participation in this study; 10. Visual or auditory impairments affecting cognitive assessments; 11. Contraindications to the use of weight-loss medications such as tirzepatide; 12. Contraindications to traditional Chinese medicine treatments such as catgut embedding or acupuncture.

Design outcomes

Primary

MeasureTime frame
The decrease in BMI from baseline at 1 month of intervention (%); ;Improvement in HOMA-IR;

Secondary

MeasureTime frame
The decrease in LDL-C;Dynamic changes in resting metabolic rate;Number of differential metabolites;Changes in microbial diversity;Comprehensive efficacy level;

Countries

China

Contacts

Public ContactPeng Fu

Shandong Provincial Third Hospital

garuda1981@126.com+86 186 7888 9967

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026