Diabete Type 2NCT05894811
A Study on the Effect of Bariatric Surgery on Glucose Metabolism in Chinese Obese and Type 2 Diabetes Patients
An observational study of Diabete Type 2 and Obesity, run by Dongyang Liu.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Diabete Type 2, Obesity
- What is being tested?
- oral glucose tolerance test and MRI
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Obese people who will undergo sleeve gastrectomy in Peking University Third Hospital and meet the admission criteria.
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
- Those with a history of other weight loss surgeries
- Individuals with a history of cardiovascular surgery and severe cardiovascular and pulmonary diseases: including stroke, severe coronary heart disease, arrhythmia, unstable angina, myocardial infarction within 6 months, peripheral vascular disease, heart failure, and uncontrolled hypertension
- Clinically significant history of ECG abnormalities or family history of long QT syndrome (grandparents, parents, brothers and sisters)
- People with a history of kidney disease: have a history or evidence of renal insufficiency, manifested as clinically significant creatinine abnormalities or urinary composition abnormalities (such as tubular abnormalities), or eGFR<60 ml/min/1.73m2
- Patients with a history of gastrointestinal surgery (excluding appendectomy and cholecystectomy), inflammatory bowel disease, esophageal disease, including severe refractory esophagitis, Barrett's disease, esophageal motility disorders, or other gastric motility impairments, or those with esophageal hiatal hernia>3cm in size, chronic or acute bleeding, including peptic ulcer disease, portal hypertension (gastric or esophageal varices), chronic pancreatitis or cirrhosis
- Individuals with a history of eating disorders or mental illness
- Individuals with a history of infectious diseases are excluded if they have any of the following: human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or those who have tested positive for syphilis
- Smokers, those who smoke more than 10 cigarettes or equivalent amounts of tobacco per day and cannot stop smoking during the trial period
- There is a history of drug or alcohol abuse within the 12 months prior to the trial, or evidence of such abuse is found during laboratory examinations during the screening period evaluation
- Women who are pregnant, breastfeeding, or planning to conceive and are unwilling to use contraception during the trial period
- Malignant tumor patients
- The researcher believes that it is not suitable for participants in the experiment
- For different types of subjects, additional exclusion criteria: obese patients with normal glucose tolerance: fasting blood glucose ≥ 7.0 mmol/L or ≤ 3.9 mmol/L (excluding diabetes and hypoglycemia)
- Obese patients before glucose: fasting blood glucose ≥ 7.0 mmol/L or ≤ 3.9 mmol/L (excluding diabetes and hypoglycemia)
- Obese T2DM patients: Fasting blood glucose ≤ 3.9 mmol/L (excluding those with hypoglycemia)
About this study
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.
Read the 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
- Being tested
- oral glucose tolerance test, MRI
- Keywords
- Diabete Type 2, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glucose tolerance testDiagnostic 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.
MRIDiagnostic test
Using MRI to quantify of fat content in the liver and pancreas of the subjects
| Study group | Role | What they receive |
|---|---|---|
| control | obese people with normal glucose tolerance Receives: Diagnostic Test: oral glucose tolerance test; Diagnostic Test: MRI | |
| IGT | obese people with injured glucose tolerance Receives: Diagnostic Test: oral glucose tolerance test; Diagnostic Test: MRI | |
| T2D | obese people with type 2 diabetes Receives: Diagnostic Test: oral glucose tolerance test; Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral fat content
Visceral fat content (MRI)
Measured: 1 day
Islet function indicators
indicators describing Islet function calculated from OGTT data using MTT model
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongyang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongyang Liu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894811
- Sponsor's protocol ID
- DCTC-IIR202307
- Status last verified
- May 2023
- First submitted
- 30 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effect of Bariatric Surgery on Glucose Metabolism in Chinese Obese and Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT05894811
- Acronym / sponsor ID
- DCTC-IIR202307
- Conditions
- Diabete Type 2, Obesity
- Keywords
- Diabete Type 2, Obesity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Dongyang LiuUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | Diagnostic Test: oral glucose tolerance test, Diagnostic Test: MRIobese people with normal glucose tolerance |
| IGT | – | Diagnostic Test: oral glucose tolerance test, Diagnostic Test: MRIobese people with injured glucose tolerance |
| T2D | – | Diagnostic Test: oral glucose tolerance test, Diagnostic Test: MRIobese people with type 2 diabetes |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Obese people who will undergo sleeve gastrectomy in Peking University Third Hospital and meet the admission criteria.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral glucose tolerance testNine 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 | IGT, T2D, control |
| MRIUsing MRI to quantify of fat content in the liver and pancreas of the subjects | Diagnostic test | IGT, T2D, control |
Primary outcome
Visceral fat content
Time frame: 1 day
Visceral fat content (MRI)
Islet function indicators
Time frame: 1 day
indicators describing Islet function calculated from OGTT data using MTT model
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 2 and Obesity, run by Dongyang Liu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral fat content (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.