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Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass)

Primary Purpose

Obesity (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mini Gastric Bypass
Roux en Y Gastric Bypass
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity (Disorder) focused on measuring Malabsorption, Mini Gastric Bypass, Roux en Y Gastric Bypass

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 40-55 kg/m2
  • Non smokers
  • Primary Mini Gastric Bypass or Roux en Y Gastric Bypass without any concomitant surgeries except hiatal hernia repair
  • Enrollment in the two study groups will be on the basis of patient choice.

Exclusion Criteria:

  • Smokers
  • Different bowel measurement (plus or minus 10%).
  • Conversion to open surgery, reoperation
  • Helicobacter Pylori positive previous or current
  • Free PPI 4 weeks before 6th month (after surgery)
  • Corticosteroids, vitamine E, fish oil treatment 2 months before surgery
  • Anti or pre- biotics treatment 2 months before surgery
  • Chronic gastrointestinal diseases or syndromes
  • Previous bariatric surgery (intragastric balloon excluded)
  • Previous resective bowel surgery
  • Previous pancreatic surgery
  • Previous Hepato BilioPancreatic surgery
  • Gallbladder gallstones

Sites / Locations

  • ICOT Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mini Gastric Bypass

Roux en Y Gastric Bypass

Arm Description

Mini Gastric Bypass: The gastric pouch will be performed starting below the incisura angularis (transverse resection 4 cm) on the lesser curvature (18).Then the stomach will be transected against a 36 Fr bougie up to the gastro-esophageal junction Then 1/3 of the small bowel will be excluded (approximately 200cms) and 3.5-4 cm gastro-jejunostomy will be performed by linear stapler.

Roux en Y Gastric Bypass: The steps of the standard double loop RYGB technique will be followed (17). The gastric pouch will be created 7 cm from the gastro-esophageal junction to obtain a volume of 30-40 ml, and the length of the alimentary limb will be 150 cm and 3.5-4 cm gastro-jejunostomy will be performed by linear stapler. The length of the biliopancreatic limb will be from 65 to 75 cm beyond the ligament of Treitz. The lengths of both limbs should carefully measured with a graduated instrument. The mesenteric defects will be closed.

Outcomes

Primary Outcome Measures

Gut Microbiota
To evaluate and compare Roux en Y Gastric Bypass vs Mini Gastric Bypass microbiota profile shift 1 year after surgery and its impact on metabolic and nutritional status after surgery.

Secondary Outcome Measures

Glucagon - like peptide 1 (GLP-1)
To measure GLP-1 plasma level before and 12 months after surgery in MGB vs RYGB patients

Full Information

First Posted
December 24, 2017
Last Updated
April 27, 2021
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT03412149
Brief Title
Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass)
Official Title
Malabsorption and Gut Microbiota Profile Changes After Laparoscopic Mini-Gastric Bypass (MGB) vs Roux-en-Y Gastric Bypass (RYGB): a Prospective Multicenter Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
February 19, 2020 (Actual)
Study Completion Date
November 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Bariatric surgery represents the best therapeutic option to induce sustainable weight loss and to solve serious comorbidities improving the life-expectancy and the quality of life. Actually the choice of the procedure is based on the surgeon's and patients preference . Mini gastric bypass(MGB) is an emerging procedure offering excellent results in terms of weight loss and comorbidities (mainly metabolic) control. On the other hand, recent data indicated that the gut microbiota may mediate some of the beneficial effects of bariatric surgery and changes in the composition and diversity of the gut microbiota have been observed after RY Gastric Bypass (RYGB) in humans as well as in mice. However, there are no prospective investigations on Gut Microbiota changes after MGB, despite the procedure is described as "malabsorptive" and there are no studies comparing gut microbiota shift and malabsorption entity in humans after RYGB vs MGB. Thereafter prospective data on the incidence of bile reflux esophageal lesions after MGB are lacking. The aim of the present multicentric prospective comparative study is to evaluate malabsorption and gut microbiota shift after laparoscopic RYGB vs MGB at 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity (Disorder)
Keywords
Malabsorption, Mini Gastric Bypass, Roux en Y Gastric Bypass

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mini Gastric Bypass
Arm Type
Active Comparator
Arm Description
Mini Gastric Bypass: The gastric pouch will be performed starting below the incisura angularis (transverse resection 4 cm) on the lesser curvature (18).Then the stomach will be transected against a 36 Fr bougie up to the gastro-esophageal junction Then 1/3 of the small bowel will be excluded (approximately 200cms) and 3.5-4 cm gastro-jejunostomy will be performed by linear stapler.
Arm Title
Roux en Y Gastric Bypass
Arm Type
Active Comparator
Arm Description
Roux en Y Gastric Bypass: The steps of the standard double loop RYGB technique will be followed (17). The gastric pouch will be created 7 cm from the gastro-esophageal junction to obtain a volume of 30-40 ml, and the length of the alimentary limb will be 150 cm and 3.5-4 cm gastro-jejunostomy will be performed by linear stapler. The length of the biliopancreatic limb will be from 65 to 75 cm beyond the ligament of Treitz. The lengths of both limbs should carefully measured with a graduated instrument. The mesenteric defects will be closed.
Intervention Type
Procedure
Intervention Name(s)
Mini Gastric Bypass
Intervention Description
Standardization of the techniques will be guaranteed: Mini Gastric Bypass Arm Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length.
Intervention Type
Procedure
Intervention Name(s)
Roux en Y Gastric Bypass
Intervention Description
Standardization of the techniques will be guaranteed: Mini Gastric Bypass Arm Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length.
Primary Outcome Measure Information:
Title
Gut Microbiota
Description
To evaluate and compare Roux en Y Gastric Bypass vs Mini Gastric Bypass microbiota profile shift 1 year after surgery and its impact on metabolic and nutritional status after surgery.
Time Frame
0-6-12 Months
Secondary Outcome Measure Information:
Title
Glucagon - like peptide 1 (GLP-1)
Description
To measure GLP-1 plasma level before and 12 months after surgery in MGB vs RYGB patients
Time Frame
0-12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 40-55 kg/m2 Non smokers Primary Mini Gastric Bypass or Roux en Y Gastric Bypass without any concomitant surgeries except hiatal hernia repair Enrollment in the two study groups will be on the basis of patient choice. Exclusion Criteria: Smokers Different bowel measurement (plus or minus 10%). Conversion to open surgery, reoperation Helicobacter Pylori positive previous or current Free PPI 4 weeks before 6th month (after surgery) Corticosteroids, vitamine E, fish oil treatment 2 months before surgery Anti or pre- biotics treatment 2 months before surgery Chronic gastrointestinal diseases or syndromes Previous bariatric surgery (intragastric balloon excluded) Previous resective bowel surgery Previous pancreatic surgery Previous Hepato BilioPancreatic surgery Gallbladder gallstones
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianfranco Silecchia, MD PhD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICOT Hospital
City
Latina
ZIP/Postal Code
04100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26661108
Citation
Milone M, De Placido G, Musella M, Sosa Fernandez LM, Sosa Fernandez LV, Campana G, Di Minno MN, Milone F. Incidence of Successful Pregnancy After Weight Loss Interventions in Infertile Women: a Systematic Review and Meta-Analysis of the Literature. Obes Surg. 2016 Feb;26(2):443-51. doi: 10.1007/s11695-015-1998-7.
Results Reference
background
PubMed Identifier
26341086
Citation
Musella M, Apers J, Rheinwalt K, Ribeiro R, Manno E, Greco F, Cierny M, Milone M, Di Stefano C, Guler S, Van Lessen IM, Guerra A, Maglio MN, Bonfanti R, Novotna R, Coretti G, Piazza L. Efficacy of Bariatric Surgery in Type 2 Diabetes Mellitus Remission: the Role of Mini Gastric Bypass/One Anastomosis Gastric Bypass and Sleeve Gastrectomy at 1 Year of Follow-up. A European survey. Obes Surg. 2016 May;26(5):933-40. doi: 10.1007/s11695-015-1865-6.
Results Reference
background
PubMed Identifier
23519905
Citation
Campanile FC, Boru CE, Rizzello M, Puzziello A, Copaescu C, Cavallaro G, Silecchia G. Acute complications after laparoscopic bariatric procedures: update for the general surgeon. Langenbecks Arch Surg. 2013 Jun;398(5):669-86. doi: 10.1007/s00423-013-1077-2. Epub 2013 Mar 22.
Results Reference
background
PubMed Identifier
11433900
Citation
Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
Results Reference
background
PubMed Identifier
16259892
Citation
Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg. 2005 Oct;15(9):1304-8. doi: 10.1381/096089205774512663.
Results Reference
background
PubMed Identifier
12413309
Citation
Alexandrou A, Davis PA, Law S, Whooley BP, Murthy SC, Wong J. Esophageal cancer in patients with a history of distal gastrectomy. Arch Surg. 2002 Nov;137(11):1238-42. doi: 10.1001/archsurg.137.11.1238.
Results Reference
background
PubMed Identifier
23011462
Citation
Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.
Results Reference
background
PubMed Identifier
25614356
Citation
Bruzzi M, Rau C, Voron T, Guenzi M, Berger A, Chevallier JM. Single anastomosis or mini-gastric bypass: long-term results and quality of life after a 5-year follow-up. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):321-6. doi: 10.1016/j.soard.2014.09.004. Epub 2014 Sep 16.
Results Reference
background
PubMed Identifier
22411569
Citation
Noun R, Skaff J, Riachi E, Daher R, Antoun NA, Nasr M. One thousand consecutive mini-gastric bypass: short- and long-term outcome. Obes Surg. 2012 May;22(5):697-703. doi: 10.1007/s11695-012-0618-z.
Results Reference
background
PubMed Identifier
21159561
Citation
Lee WJ, Lee YC, Ser KH, Chen SC, Chen JC, Su YH. Revisional surgery for laparoscopic minigastric bypass. Surg Obes Relat Dis. 2011 Jul-Aug;7(4):486-91. doi: 10.1016/j.soard.2010.10.012. Epub 2010 Oct 30.
Results Reference
background
PubMed Identifier
15946455
Citation
Wang W, Wei PL, Lee YC, Huang MT, Chiu CC, Lee WJ. Short-term results of laparoscopic mini-gastric bypass. Obes Surg. 2005 May;15(5):648-54. doi: 10.1381/0960892053923752.
Results Reference
background
PubMed Identifier
27418681
Citation
Cavin JB, Voitellier E, Cluzeaud F, Kapel N, Marmuse JP, Chevallier JM, Msika S, Bado A, Le Gall M. Malabsorption and intestinal adaptation after one anastomosis gastric bypass compared with Roux-en-Y gastric bypass in rats. Am J Physiol Gastrointest Liver Physiol. 2016 Sep 1;311(3):G492-500. doi: 10.1152/ajpgi.00197.2016. Epub 2016 Jul 14.
Results Reference
background
PubMed Identifier
23032991
Citation
Graessler J, Qin Y, Zhong H, Zhang J, Licinio J, Wong ML, Xu A, Chavakis T, Bornstein AB, Ehrhart-Bornstein M, Lamounier-Zepter V, Lohmann T, Wolf T, Bornstein SR. Metagenomic sequencing of the human gut microbiome before and after bariatric surgery in obese patients with type 2 diabetes: correlation with inflammatory and metabolic parameters. Pharmacogenomics J. 2013 Dec;13(6):514-22. doi: 10.1038/tpj.2012.43. Epub 2012 Oct 2.
Results Reference
background
PubMed Identifier
26244932
Citation
Tremaroli V, Karlsson F, Werling M, Stahlman M, Kovatcheva-Datchary P, Olbers T, Fandriks L, le Roux CW, Nielsen J, Backhed F. Roux-en-Y Gastric Bypass and Vertical Banded Gastroplasty Induce Long-Term Changes on the Human Gut Microbiome Contributing to Fat Mass Regulation. Cell Metab. 2015 Aug 4;22(2):228-38. doi: 10.1016/j.cmet.2015.07.009.
Results Reference
background
PubMed Identifier
23536013
Citation
Liou AP, Paziuk M, Luevano JM Jr, Machineni S, Turnbaugh PJ, Kaplan LM. Conserved shifts in the gut microbiota due to gastric bypass reduce host weight and adiposity. Sci Transl Med. 2013 Mar 27;5(178):178ra41. doi: 10.1126/scitranslmed.3005687.
Results Reference
background
PubMed Identifier
27036669
Citation
Peterson LA, Zeng X, Caufield-Noll CP, Schweitzer MA, Magnuson TH, Steele KE. Vitamin D status and supplementation before and after bariatric surgery: a comprehensive literature review. Surg Obes Relat Dis. 2016 Mar-Apr;12(3):693-702. doi: 10.1016/j.soard.2016.01.001. Epub 2016 Jan 6.
Results Reference
background
PubMed Identifier
18069071
Citation
Madan AK, Harper JL, Tichansky DS. Techniques of laparoscopic gastric bypass: on-line survey of American Society for Bariatric Surgery practicing surgeons. Surg Obes Relat Dis. 2008 Mar-Apr;4(2):166-72; discussion 172-3. doi: 10.1016/j.soard.2007.08.006. Epub 2007 Dec 19.
Results Reference
background
PubMed Identifier
27091050
Citation
Musella M, Milone M, Deitel M, Kular KS, Rutledge R. What a Mini/One Anastomosis Gastric Bypass (MGB/OAGB) Is. Obes Surg. 2016 Jun;26(6):1322-3. doi: 10.1007/s11695-016-2168-2. No abstract available.
Results Reference
background
PubMed Identifier
21542694
Citation
Donini LM, Brunani A, Sirtori A, Savina C, Tempera S, Cuzzolaro M, Spera G, Cimolin V, Precilios H, Raggi A, Capodaglio P; SIO-ISDCA Task Force. Assessing disability in morbidly obese individuals: the Italian Society of Obesity test for obesity-related disabilities. Disabil Rehabil. 2011;33(25-26):2509-18. doi: 10.3109/09638288.2011.575529. Epub 2011 May 4.
Results Reference
background

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Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass)

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