Effect of Laparoscopic Roux-en-Y Gastric Bypass Surgery on Non-severe Obesity With Type 2 Diabete… (NCT02091323) | Clinical Trial Compass
UnknownNot Applicable
Effect of Laparoscopic Roux-en-Y Gastric Bypass Surgery on Non-severe Obesity With Type 2 Diabetes Mellitus
China200 participantsStarted 2014-03
Plain-language summary
The effect of roux-en-Y gastric bypass(RYGB) on patients with type 2 diabetes mellitus(T2DM) and a body mass index(BMI)\>35kg/m2 is clear. There are large-scale patients with T2DM in Chinese population and currently about two-thirds of them are lack of adequate blood glucose control. Asian Chinese have different type of obesity, different style of diet, and a relatively low BMI levels as well. We assess the feasibility and efficacy of laparoscopic roux-en-Y gastric bypass surgery (LRYGB) in patients with non-severely obese T2DM.Taking into account the differences of body size and diet between the United States \& Europe and Asian countries, diabetic situation has its special features in different regions, especially in Asia China. Asian Chinese have a high incidence of T2DM and a relatively low BMI levels. Evaluating the benefits from LRYGB for T2DM in Asian Chinese diabetes subjects with a body mass index of less than 35kg/m2 and looking for sufficient evidence to this operation become necessary.The patients will be followed up for one year after surgery and a comparison would be made between the two groups. Clinical indicators that reflect the effect of LRYGB are monitored before surgery and 1, 3,6,12 months after surgery. Complete remission of diabetes was defined by hemoglobin A1c (HbA1c)\<6.0% and Fasting plasma glucose (FPG)\<5.6mmol/L.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose(PG) ≥200 mg/dL(11.1 mmol/L) or fasting plasma glucose (FPG) ≥ 7 .0 mmol / L or Two-hour PG ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test(OGTT) or HbA1c \> 6.5% .The study candidates were included if they had any of the following features:
* exclusion of type 1 diabetes mellitus(T1DM) ;
* BMI ≤ 35 kg/㎡ or waist circumference \>90cm;
* duration of T2DM less than 15 years ;
* age ≤ 65 years ;
* islet functional reserve :fasting C-peptide (FC-P) normal or more , postprandial two-hour C-peptide response more than 2 times compared with a pre-dinner ;
* poor control of medical treatment ,glycated hemoglobin (HbA1c) ≥ 7 .0%;
* volunteer to accept LRYGB surgery and sign the consent
Exclusion Criteria:
* type 1 diabetes mellitus
* age \>65 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
fasting plasma glucose(FPG)
Timeframe: up to 36 months after surgery
Trial details
NCT IDNCT02091323
SponsorGuangzhou General Hospital of Guangzhou Military Command