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Diabetes Mellitus, Non-Insulin-DependentNCT02091323

Effect of Laparoscopic Roux-en-Y Gastric Bypass Surgery on Non-severe Obesity With Type 2 Diabetes Mellitus

A study testing gastric bypass surgery in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Non-Insulin-Dependent
What is being tested?
gastric bypass surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
Mar 2014to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
  • type 1 diabetes mellitus
  • age >65 years

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Wu

    Guangzhou, Guangdong, 510010

    Liangping Wu, drwulp@163.com

    Yongtao Huang, zsh2014@foxmail.com

    Recruiting

Other trials in China

About this study

Official title: Effect of Modified Laparoscopic Roux-en-Y Gastric Bypass Surgery on Type 2 Diabetics With Lower Body Mass Index in China

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.

Read the detailed description

Type 2 diabetes mellitus (T2DM) is well known as a chronic metabolic disease. As the main manifestation of T2DM , the disorder of glucose metabolism which is due to the gradual dysfunction of pancreatic islet and significant insulin resistance results in many problems and complications associated with T2DM such as hypertension, cardiovascular diseases(CVD), lipid disorders and other complications. Currently, there are more than 346 million people suffered from T2DM worldwide, among which T2DM accounts for about 90%. A report published by Chinese diabetes and metabolic syndrome research group in 2010 showed that overall prevalence of diabetes is 9.7% over the age of 20 and the total number of diabetes mellitus has reached 92.4 million in Chinese population and what's worse, more than 15.5 percent of adults are in the pre-diabetic state. Through traditional diet therapy, exercise, changing lifestyle, and standardized medical treatment have a certain effect on diabetes and its complications, T2DM can't be cured so far. How to cure diabetes mellitus and improve the quality of life of diabetic patients is a common problem faced by doctors in all countries. In 1984, Pories et al have found that glucose metabolism indicators significantly improved when he analyzed a report of three-year progress results of obesity patients with T2DM after laparoscopic Roux-en-Y gastric bypass surgery(LRYGB) , thus opening a door to the surgical treatment for diabetes. Now LRYGB is often performed in Europe and United State, and has been written into the diabetes treatment guidelines by American Diabetes Association in 2009. The surgical treatment for diabetes is an extension from the surgical treatment for morbid obesity. So diabetes treatment guidelines in 2014 show that bariatric surgery may be considered for T2DM with a body mass index (BMI) >35 kg/m2, especially if diabetes or associated comorbidities are difficult to control with lifestyle and pharmacological therapy. However, it also mentioned that small trials have shown benefit in patients with type 2 diabetes mellitus and BMI 30-35 kg/m2 after bariatric surgery. But it still lacks sufficient evidence for patients with BMI below 30kg/m2. A survey conducted in Shanghai, China, showed that the prevalence of type 2 diabetes was 9.8%, while the prevalence of obesity was 4.3%.But in the United States, the incidence of type 2 diabetes was 10.9% and the obesity population defined by a BMI ≥30 kg/m2 may account for one third of the total population in 2009-2010. In addition, patients in Asian countries are mostly abdominal obesity compared with that of patients in the United States and Europe where have different type of obesity. 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.

Being tested
gastric bypass surgery
Keywords
T2DM, gastric bypass surgery, BMI<35, 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.

  • gastric bypass surgeryProcedure or surgery

    Also called Roux-en-Y Gastric Bypass Surgery

    With the patient under intubation and general anesthesia, a pneumoperitoneum was created and the pressure was set to 15 mmHg. All LRYGB operations were performed using four trocars. Separate cardiac angle and hepatogastric ligament from the left gastric artery between 2 and 3 branch by hanging liver on the abdominal wall so as to enter into the lesser sac. Reveal the ligament of Treitz, lift the jejunum from the Treitz ligament 75 ~ 150 cm, connect the distal jejunum to the posterior wall of the stomach with a linear cutting staple by an end-to-side anastomosis and suture the common opening at last.

Study groups in NCT02091323
Study groupRoleWhat they receive
BMI<28kg/m2ExperimentalIndicators monitored preoperatively and at 1,3,6,12 months after surgery in BMI<28kg/m2 group.
Receives: Procedure: gastric bypass surgery
controlOtherIndicators monitored preoperatively and at 1,3,6,12 months after surgery in BMI>28kg/m2 group as well.
Receives: Procedure: gastric bypass surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fasting plasma glucose(FPG)

    Measured: up to 36 months after surgery

Secondary outcomes (1)
  1. hemoglobin A1c (HbA1c)

    Measured: HbA1c will be monitored preoperatively and at 1,3,6,12 ,24,36months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02091323
Sponsor's protocol ID
Lrygb2014
Status last verified
Jan 2015
First submitted
12 Mar 2014
Last updated
27 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Cotillard A, Poitou C, Duchateau-Nguyen G, Aron-Wisnewsky J, Bouillot JL, Schindler T, Clement K. Type 2 Diabetes Remission After Gastric Bypass: What Is the Best Prediction Tool for Clinicians? Obes Surg. 2015 Jul;25(7):1128-32. doi: 10.1007/s11695-014-1511-8.

    PubMed 25387683
  • Luger M, Kruschitz R, Langer F, Prager G, Walker M, Marculescu R, Hoppichler F, Schindler K, Ludvik B. Effects of omega-loop gastric bypass on vitamin D and bone metabolism in morbidly obese bariatric patients. Obes Surg. 2015 Jun;25(6):1056-62. doi: 10.1007/s11695-014-1492-7.

    PubMed 25381120
  • Torriani M, Oliveira AL, Azevedo DC, Bredella MA, Yu EW. Effects of Roux-en-Y gastric bypass surgery on visceral and subcutaneous fat density by computed tomography. Obes Surg. 2015 Feb;25(2):381-5. doi: 10.1007/s11695-014-1485-6.

    PubMed 25381117
  • Chen Y, Zeng G, Tan J, Tang J, Ma J, Rao B. Impact of roux-en Y gastric bypass surgery on prognostic factors of type 2 diabetes mellitus: meta-analysis and systematic review. Diabetes Metab Res Rev. 2015 Oct;31(7):653-62. doi: 10.1002/dmrr.2622. Epub 2014 Dec 17.

    PubMed 25387821

Questions about this trial

What is this clinical trial studying?

A study testing gastric bypass surgery in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.

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 0 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fasting plasma glucose(FPG) (time frame: up to 36 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02091323, which also lists 4 linked publications.

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 27 Jan 2015.

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