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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-65
SponsorDongyang Liu

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • oral glucose tolerance test
  • MRI

Treatment groups

48 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Dongyang Liu

Lead sponsor

Peking University Third Hospital

Sponsor institution