NCT05894811

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 48 (estimated)
• Sponsor: Dongyang Liu · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabete Type 2
• Obesity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	oral glucose tolerance test	Nine blood samples were collected from subjects within 4 hours of oral glucose administration, 0 min before oral glucose administration, and 10, 20, 30, 60, 90, 120, 180, 240 min afterwards, and 4 mL of venous blood was collected at each time point for glucose, C-peptide and insulin concentrations.
DIAGNOSTIC_TEST	MRI	Using MRI to quantify of fat content in the liver and pancreas of the subjects

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-06-08
• Last updated: 2023-06-08