A Study on the Effect of Bariatric Surgery on Glucose Metabolism in Chinese Obese and Type 2 Diabetes Patients

Dongyang Liu0 sites48 target enrollmentJune 1, 2023

Overview

Brief Summary

The study will be conducted in the following population: obese patients with normal glucose tolerance (HbA1c ≤ 5.6%, n=12), pre-sugar patients (5.7% ≤ HbA1c ≤ 6.4%, n=18) and patients with T2DM (HbA1c ≥ 6.4% , n=18). After recruiting, they were followed up at 1, 3, 6, and 12 months postoperatively, and their preoperative and follow-up examination values related to demographics, body composition, blood biochemistry, and glucose metabolic balance, as well as quantitative MRI imaging and oral glucose tolerance test (OGTT) will be collected. An interim analysis will be performed at 6 months postoperatively and overall analysis will be performed at 12 months postoperatively by descriptive statistics and ANOVA methods to explore the effect of adiposity on the progression of diabetes mellitus and insulin secretory function.

Detailed Description

The study will be conducted in the following population: obese patients with normal glucose tolerance (HbA1c ≤ 5.6%, n=12), pre-sugar patients (5.7% ≤ HbA1c ≤ 6.4%, n=18) and patients with T2DM (HbA1c ≥ 6.4% , n=18). After recruiting, they were followed up at 1, 3, 6, and 12 months postoperatively, and their preoperative and follow-up examination values related to demographics, body composition, blood biochemistry, and glucose metabolic balance, as well as quantitative MRI imaging and oral glucose tolerance test (OGTT) will be collected. An interim analysis will be performed at 6 months postoperatively and overall analysis will be performed at 12 months postoperatively by descriptive statistics and ANOVA methods to explore the effect of adiposity on the progression of diabetes mellitus and insulin secretory function.

Registry

clinicaltrials.gov

Start Date

June 1, 2023

End Date

December 1, 2026

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Dongyang Liu

Responsible Party

Sponsor Investigator

Principal Investigator

Dongyang Liu

researcher

Peking University Third Hospital

Eligibility Criteria

Inclusion Criteria

•BMI ≥ 28 kg/m2, meeting the indications for surgical weight loss surgery (gastrectomy)
•Normal glucose tolerance group: HbA1c ≤ 5.6%; ≥ 6 cases aged 24 years or above
•IGT patients: 5.7% ≤ HbA1c ≤ 6.4%; ≥ 12 cases aged 24 years or above
•T2DM patients: Subjects with HbA1c ≥ 6.4% or HbA1c well controlled by medication can be diagnosed as T2DM based on self-reported or fasting/postprandial blood glucose diagnosis; ≥ 12 cases aged 24 years and above.
•Between the ages of 16 and 65 (inclusive), with no less than one-third of either gender
•The subjects understand the content of the informed consent form and voluntarily sign it, which allows them to maintain good communication with the researchers and comply with the requirements of the clinical trial

Exclusion Criteria

•Type I diabetes patients (autoimmune diabetes patients with T1DM antibody)
•Suffering from special types of diabetes, including cortisolism, growth hormone tumor, glucagon tumor and diabetes caused by some genetic factors
•Significant weight loss occurred before enrollment (\>3% weight loss in the first 3 months)
•Participated in other research projects as a subject within 6 months prior to screening
•Donate or lose ≥ 400 mL of blood within 8 weeks prior to screening
•Regular use (cumulative use for 3 months in the past 12 months) or treatment with corticosteroids, contraceptives, thiazide diuretics, and quinolone antibiotics in the past two months
•Regular use (cumulative use for 3 months in the past 12 months) or treatment with anti obesity drugs in the past two months
•The following hypoglycemic drugs have been used routinely (for 3 months accumulatively in the past 12 months) or in the past two months: sulfonylureas (glibenclamide, glipizide, gliclazide, gliquidone, glimepiride, etc.), non sulfonylureas (repaglinide, nateglinide, migglinide, etc.), GLP-1 receptor agonists (exenatide, lilalutide, etc.) DPP-4 inhibitors (sigliptin, alogliptin, vildagliptin, shagliptin, linagliptin, etc.) or glucokinase agonists (doegliptin, etc.)
•Contraindications to magnetic resonance imaging
•The risk of complications significantly increases during the perioperative or postoperative period