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

ConditionsDiabete Type 2 Obesity

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

This trial does not accept healthy volunteers

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 population

Obese people who will undergo sleeve gastrectomy in Peking University Third Hospital and meet the admission criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

oral glucose tolerance test
Diagnostic 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.
MRI
Diagnostic test
Using MRI to quantify of fat content in the liver and pancreas of the subjects

Treatment groups

48 Participants

are divided into 3 treatment groups

Group A: control2 interventions

Group B: IGT2 interventions

Group C: T2D2 interventions

Trial outcomes

Primary outcomes

Visceral fat content

Visceral fat content (MRI)

Time frame

1 day

Islet function indicators

indicators describing Islet function calculated from OGTT data using MTT model

Time frame

1 day

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dongyang Liu

Lead sponsor

Peking University Third Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: