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Intestinal flora and hormone-related study in people undergoing endoscopic sleeve gastroplasty for weight loss

Intestinal flora and hormone-related study in people undergoing endoscopic sleeve gastroplasty for weight loss

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095883
Enrollment
Unknown
Registered
2025-01-15
Start date
2025-02-07
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

obesity

Interventions

treatment group (Endoscopic sleeve gastroplasty):none
control group:none

Sponsors

Beijing Friendship Hospital ,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age range of 18-60 years old (including 18 and 60 years old), male or female not limited; 2. 30kg/m^2 <= BMI <40kg/m^2; 3. The ASA classification is grade I - II; 4. Patients understand the purpose of the trial, voluntarily participate in the trial, and sign informed consent; 5. The patient agreed to undergo follow-up evaluation, laboratory examination, and dietary intervention as required by the protocol;

Exclusion criteria

Exclusion criteria: 1.History of upper gastrointestinal surgery (except cholecystectomy); 2.Have undergone open or laparoscopic bariatric surgery; 3.Active peptic ulcer; 4.Patients with bleeding or potential bleeding conditions in the digestive tract, such as esophageal or fundus varicose veins, intestinal telangiectasia, etc; 5.Accompanied by advanced malignant tumors of digestive tract or other organs; 6.Diagnosed with type 1 diabetes; 7.Islet beta cell function has been basically lost, C-peptide = 1/2 of the normal low limit or the C-peptide release curve under glucose load is low; 8.Has a difficult mental illness to control; 9.Current drug or alcohol abuse problems; 10.According to the researchers' judgment, patients with poor systemic condition and contraindication of endoscopy exist; 11.Patients with coagulation function deemed unsuitable for endoscopic surgery; 12.Patients with severe hepatic and renal dysfunction with a creatinine concentration greater than 180µmol/L; 13.Patients with severe infection that is not under control and is not suitable for surgery; 14.Pregnant and lactating women; 15.Women who have planned a pregnancy within the last 1 year; 16.Inability or unwillingness to use proton pump inhibitors; 17.Patients who require regular use of non-steroidal anti-inflammatory drugs, including aspirin, diclofenac, ibuprofen, naproxen, or other known stomach irritants; 18.Untreated or uncontrolled thyroid dysfunction; 19.Patients who had taken corticosteroids, immunosuppressants, anesthetics, and weight loss drugs in the 28 days prior to surgery; 20.NYHA patients with cardiac function grade III or above or pulmonary dysfunction; 21.Patients with a narrow pharynx or esophagus that cannot be passed through an endoscope; 22.Participants who have participated in any clinical trial and received investigational drug or device therapy within 3 months prior to screening; 23.Allergic to polypropylene, titanium alloy and other materials; 24.Eating disorders, including anorexia or binge eating; 25.Patients who are prepared to undergo surgical weight loss surgery of their choice within the next year; 26.Patients with any other condition that the investigator deems inappropriate to participate in this trial;

Design outcomes

Primary

MeasureTime frame
feeding hormones;

Secondary

MeasureTime frame
Intestinal flora lineage;

Countries

China

Contacts

Public ContactWei Yongqiu

Beijing Friendship Hospital ,Capital Medical University

weiyongqiu@ccmu.edu.cn+86 10 6313 8650

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026