The Effects of the Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Mini Gastric Bypass on the Remission of Type II Diabetes Mellitus

NCT ID: NCT03330756

Last Updated: 2017-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2021-11-01

Brief Summary

It is estimated that there will be 439-552 million people with type 2 diabetes mellitus (T2DM) globally in 2030. Type 2 Diabetes Mellitus is present in one quarter of patients at the bariatric outpatient clinic. It is undecided which metabolic surgery grants best results in the remission of T2DM and which procedure does that at the lowest rate of surgical complications, long term difficulties and side effects. Non alcoholic fatty liver disease (NAFLD) is present in 80% of all morbidly obese subjects and is a major risk factor for development of insulin resistance and non alcoholic steatohepatis (NASH). It is increasingly recognized that the immune system, possibly driven by innate lymphoid cells (ILC's), and the intestinal microbiome are major players in this obesity related disease and the switch from benign to malign (insulin resistance and T2DM) obesity. However, the exact mechanisms of action behind the surgery-driven switch back from malign to benign obesity are unknown.Primary objective is to evaluate and compare the glycaemic control in T2DM within the first year of LRYGB and LMBG. Secondary aim is to gain insight in the pathophysiological mechanisms that drive the conversion of malign to benign obesity.

Detailed Description

Metabolic surgery has proven to be a viable long-term solution in the treatment of morbid obesity and its comorbidities. It induces rapid remission of type 2 diabetes mellitus (T2DM). Type 2 Diabetes Mellitus is present in one quarter of patients at the bariatric outpatient clinic. Non alcoholic fatty liver disease (NAFLD) is present in 80% of all morbidly obese subjects and is a major risk factor for development of insulin resistance and non alcoholic steatohepatis (NASH), with the latter becoming the major indication for liver transplantation in the USA. It is increasingly recognized that the immune system, possibly driven by innate lymphoid cells (ILC's), and the intestinal microbiome are major players in this obesity related disease and the switch from benign to malign (insulin resistance and T2DM) obesity. However, the exact mechanisms of action behind the surgery-driven switch back from malign to benign obesity are unknown. Also, it is undecided which metabolic surgery grants best results in the remission of T2DM and which procedure does that at the lowest rate of surgical complications, long term difficulties and side effects. The Laparoscopic Roux-en-Y Gastric Bypass (LRYGB), an efficient but complex procedure, is the golden standard in the Netherlands. The Laparoscopic Mini Gastric Bypass (LMGB) is technically less challenging and has been introduced to overcome some of the limitations of LRYGB. It has been hypothesized that the LMGB has a more rapid and durable glycaemic control, possibly due to the altered constitution and the augmented length of the biliary limb. There is reason to believe that the improved glycaemic control might become apparent within the first year of surgery and that it might remain thereafter. However, it is unknown what order of magnitude is to be expected and whether subgroups of T2DM patients will benefit the LMGB more. Also, it is unknown whether and to what extent intestinal microbiota and immunological tone can predict the metabolic response (improvement in insulin sensitivity) and NAFLD/NASH reduction and whether differences are expected between these two surgeries. Increased understanding of the pathophysiological mechanisms as well as their relationship to metabolic disturbances are thought to be of crucial importance to discover new diagnostic and therapeutical targets in obesity associated insulin resistance/T2DM and NAFLD/NASH. Primary objective is to evaluate and compare the glycaemic control in T2DM within the first year of LRYGB and LMBG. Secondary aim is to gain insight in the pathophysiological mechanisms that drive the conversion of malign to benign obesity.

Conditions

Obesity, Morbid; Type 2 Diabetes Mellitus

Keywords

Roux-en-Y gastric bypass; Mini gastric bypass; Type 2 diabetes mellitus; Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic Roux-en-Y gastric bypass

Laparoscopic Roux-en-Y gastric bypass

Group Type: ACTIVE_COMPARATOR

laparoscopic Roux-en-Y gastric bypass

Intervention Type: PROCEDURE

laparoscopic Roux-en-Y gastric bypass with a 50 cm biliary limb and a 150 cm alimentary limb

Laparoscopic Mini Gastric Bypass

laparoscopic Mini gastric bypass

Group Type: EXPERIMENTAL

laparoscopic Mini gastric bypass

Intervention Type: PROCEDURE

laparoscopic Mini gastric bypass with a gastrojejunostomy at 200 centimeters measured from the ligament of Treitz

Interventions

laparoscopic Roux-en-Y gastric bypass

laparoscopic Roux-en-Y gastric bypass with a 50 cm biliary limb and a 150 cm alimentary limb

Intervention Type: PROCEDURE

laparoscopic Mini gastric bypass

laparoscopic Mini gastric bypass with a gastrojejunostomy at 200 centimeters measured from the ligament of Treitz

Intervention Type: PROCEDURE

Other Intervention Names

gastric bypass; One anastomosis gastric bypass, omega loop gastric bypass

Eligibility Criteria

Inclusion Criteria

• BMI ≥35 and ≤50 kg/m2
• Diagnosis and treatment of T2DM at intake at bariatric ward with use of anti-diabetic medication.
• American Society of Anaesthesiologist Classification (ASA) ≤3
• All patients are required to lose 6 kilograms of weight prior to surgery

Exclusion Criteria

• Known genetic basis for insulin resistance or glucose intolerance
• Type 1 DM
• Prior Bariatric surgery
• Patients requiring a concomitant intervention (such as cholecystectomy, ventral hernia repair)
• Auto-immune gastritis
• Known presence of gastro-esophageal reflux disease
• Known presence of large hiatal hernia requiring concomitant surgical repair
• Coagulation disorders (PT time > 14 seconds, aPTT ((dependent on laboratory methods) or known presence of bleeding disorders (anamnestic))
• Known presence of hemoglobinopathy
• Uncontrolled hypertension (RR > 150/95 mmHg)
• Renal insufficiency (creatinine > 150 umol/L)
• Pregnancy
• Breastfeeding
• Alcohol or drug dependency
• Primary lipid disorder
• Participation in any other (therapeutic) study that may influence primary or secondary outcomes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

Slotervaart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurits de Brauw, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Head of department of Surgery

Locations

medical Center Slotervaart

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Anne-Sophie van Rijswijk, MD

Role: CONTACT

Phone: +31205124460

Email: anne-sophie.vanrijswijk@slz.nl

Maurits de Brauw, MD PhD

Role: CONTACT

Email: maurits.debrauw@slz.nl

Facility Contacts

Anne-Sophie van Rijswijk, MD

Role: primary

Maurtis de Brauw, MD PhD

Role: backup

References

Pyykko JE, Hinnen C, Aydin O, Nieuwdorp M, De Brauw LM, Bruin SC, van Olst N, Gerdes VEA, Sanderman R, Hagedoorn M. Attachment style and post-bariatric surgery health behaviours: the mediating role of self-esteem and health self-efficacy. BMC Psychol. 2023 Aug 25;11(1):248. doi: 10.1186/s40359-023-01273-5.

Reference Type: DERIVED

PMID: 37626349 (View on PubMed)

van Rijswijk A, van Olst N, Meijnikman AS, Acherman YIZ, Bruin SC, van de Laar AW, van Olden CC, Aydin O, Borger H, Beuers UHW, Herrema H, Verheij J, Apers JA, Backhed F, Gerdes VEA, Nieuwdorp M, de Brauw LM. The effects of laparoscopic Roux-en-Y gastric bypass and one-anastomosis gastric bypass on glycemic control and remission of type 2 diabetes mellitus: study protocol for a multi-center randomized controlled trial (the DIABAR-trial). Trials. 2022 Oct 22;23(1):900. doi: 10.1186/s13063-022-06762-3.

Reference Type: DERIVED

PMID: 36273149 (View on PubMed)

Other Identifiers

P1729

Identifier Type: -

Identifier Source: org_study_id