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

NCT02091323 | Unknown

• 1 other identifier: Lrygb2014
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Keywords

T2DM, gastric bypass surgery, BMI<35, obesity

Outcome Measures

Primary Outcomes (1)

• fasting plasma glucose(FPG)

  up to 36 months after surgery

Secondary Outcomes (1)

• hemoglobin A1c (HbA1c)

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

Other Outcomes (1)

• weight loss

  weight loss will be monitored preoperatively and at 1,3,6,12,24,36 months after surgery

Study Arms (2)

BMI<28kg/m2

EXPERIMENTAL

Indicators monitored preoperatively and at 1,3,6,12 months after surgery in BMI\<28kg/m2 group.

Procedure: gastric bypass surgery

control

OTHER

Indicators monitored preoperatively and at 1,3,6,12 months after surgery in BMI\>28kg/m2 group as well.

Procedure: gastric bypass surgery

Interventions

gastric bypass surgery PROCEDURE

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.

Also known as: Roux-en-Y Gastric Bypass Surgery

BMI<28kg/m2; control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• type 1 diabetes mellitus
• age \>65 years

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

Wu

Guangzhou, Guangdong, 510010, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 25387683 BACKGROUND

• 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.

  PMID: 25381120 BACKGROUND

• 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.

  PMID: 25381117 BACKGROUND

• 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.

  PMID: 25387821 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 19, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

CN (1)