The Effects of the Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Mini Gastric Bypass on the Remission of Type II Diabetes Mellitus
DIABAR
1 other identifier
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2017
CompletedStudy Start
First participant enrolled
October 23, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedNovember 9, 2017
November 1, 2017
4 years
October 13, 2017
November 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
glycaemic control
as measured by the difference in HBa1C
12 months FU
Secondary Outcomes (21)
glycaemic control
6 and 24 months FU
glycaemic control
6, 12 and 24 months FU
Insulin sensitivity
baseline, 12, 24 months FU
NAFLD/NASH
day of surgery, reoperation
Presence of bacterial DNA/bacterial metabolites - portal vein
day of surgery, reoperation
- +16 more secondary outcomes
Study Arms (2)
Laparoscopic Roux-en-Y gastric bypass
ACTIVE COMPARATORLaparoscopic Roux-en-Y gastric bypass
Laparoscopic Mini Gastric Bypass
EXPERIMENTALlaparoscopic Mini gastric bypass
Interventions
laparoscopic Roux-en-Y gastric bypass with a 50 cm biliary limb and a 150 cm alimentary limb
laparoscopic Mini gastric bypass with a gastrojejunostomy at 200 centimeters measured from the ligament of Treitz
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
medical Center Slotervaart
Amsterdam, North Holland, 1066EC, Netherlands
Related Publications (2)
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.
PMID: 37626349DERIVEDvan 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.
PMID: 36273149DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maurits de Brauw, MD PhD
Head of department of Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2017
First Posted
November 6, 2017
Study Start
October 23, 2017
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
November 9, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share