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

NCT05894811 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2023-06-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Dongyang Liu

    lead OTHER

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2026-06-01
Completion
2026-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894811 on ClinicalTrials.gov