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Protocol for an open-label, single-center, randomised controlled trial comparing the effects of injection of glucagon-like peptide 1 receptor agonist semaglutide before bariatric surgery on diabetes remission in obese type 2 diabetes patients

Protocol for an open-label, single-center, randomised controlled trial comparing the effects of injection of glucagon-like peptide 1 receptor agonist semaglutide before bariatric surgery on diabetes remission in obese type 2 diabetes patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053486
Enrollment
Unknown
Registered
2021-11-22
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

Type 2 diabetes mellitus

Interventions

Preoperative GLP-1 Group:injection of glucagon-like peptide 1 receptor agonist before metabolic surgery
Preoperative non-GLP-1 Group:without glucagon-like peptide 1 receptor agonist before metabolic surgery

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Aged 18 to 60 years who had been diagnosed with type 2 diabetes, had a body-mass index of 35kg/m^2 and more.

Exclusion criteria

Exclusion criteria: 1. Severe liver and kidney disease (eGFR<60ml/min), malignant tumor, thyroid, Cushing's syndrome and other endocrine diseases; 2. Acute coronary syndrome, uncontrolled heart failure, weight loss of more than 10Kg in the past 6 months, GLP-1 receptor agonist used in the past 1 year, pregnancy or lactation; 3. The researchers believe that other reasons are not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Glycated hemoglobin;—

Secondary

MeasureTime frame
fasting blood glucose;percent of body fat;blood pressure;weight;levels of lipids;urine albumin creatine ratio;ophthalmologic outcomes;adverse events;quality of life;—

Countries

China

Contacts

Public ContactMeng Hua

China-Japan Friendship Hospital

menghuade@hotmail.com+86 18611457779

Outcome results

None listed

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