The Effect of Bariatric Procedures on Gut Microbiota in Obese Individuals in United Arab Emirates and Lebanon

NCT04200521 | Unknown DMC

• 1 other identifier: 1234
• Study Type: observational
• Target: 160
• Locations: 2 countries
• Sites: 2

Brief Summary

Overweight and obesity are worldwide health problems that can affect negatively quality of life. With increasing prevalence of obesity and the failure of compliance to lifestyle, bariatric surgeries have become the treatment of choice to help achieve long term sustainable weight loss. In some cases of bariatric surgery, weight loss stops and there are cases in which obesity manifests itself again; the mechanism underlying the re-appearance of obesity is not known. Recently, the gut microbiota, has been implicated in the etiology of obesity and metabolic syndrome due to its important role in digestion, metabolism and regulating gut peptides and hormones. In accordance with this, it has been shown in mice that obesity can be associated with dysbiosis (Imbalance in gut bacteria) and there has been successful reduction of weight in interventions when microbiota was manipulated. Hypothesis:

1. 1.Emirati participants will have unique microbiota and gut peptides when compared to Lebanese participants.
2. 2.The microbiota and gut peptides variability is significantly different between those with normal weight compared to obese participants undergoing bariatric surgery.
3. 3.The bariatric procedure will have a significant effect on the variability of microbiota, gut peptides, blood chemistry, dietary intake and metabolism among the obese participants.
4. 4.Determine the gut microbiota composition of Emirati healthy normal weight participants and compare to that of Lebanese via Illumina sequencing NGS (Next Generation Sequencing of the 16S rRNA gene) of the microbiota from the stool samples.
5. 5.Determine the gut microbiota composition of Emirati obese participants and compare to that of Lebanese counterparts using NGS.
6. 6.Determine the effect of bariatric procedure in UAE and Lebanon respectively on gut microbiota (using NGS), gut peptides in plasma, blood chemistry and metabolism using indirect calorimetry and food intake.

Conditions

Bariatric Surgery; Microbiota; Obesity; Dysbiosis

Keywords

Gut peptide; Energy metabolism; Appetite

Outcome Measures

Primary Outcomes (1)

• Changes in Gut Microbiota composition in obese participants

  Using Illumina sequencing NGS (Next Generation Sequencing of the 16S rRNA gene) of the microbiota from the stool samples.

  Baseline and 3 months post bariatric surgery

Secondary Outcomes (14)

• Changes in plasma level of CCK Hormone in obese participants

  Baseline and 3 months post bariatric surgery

• Changes in plasma level of PYY Hormone in obese participants

  Baseline and 3 month post bariatric surgery

• Changes in plasma level of Ghrelin Hormone in obese participants

  Baseline and 3 month post bariatric surgery

• Changes in plasma level of Leptin Hormone in obese participants

  Baseline and 3 month post bariatric surgery

• Changes in plasma level of Insulin Hormone in obese participants

  Baseline and 3 month post bariatric surgery

Study Arms (2)

Healthy weight individuals

Cross-sectional observation on healthy participants who will be recruited from the general population from both genders (Lebanese and Emirati Subjects).

Obese individuals

Prospective study of 3 months duration (pre and post design) on obese Emirati and Lebanese participants undergoing bariatric procedure irrelevant of the study, from Qassimi Hospital In sharja and Middle East Institute of Health University Hospital, Lebanon

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Forty Emirati obese adults from UAE and 40 Lebanese obese adults from Lebanon from both genders and planning to undergo bariatric procedure (irrelevant of the study) will be recruited. All participants planning to conduct the surgery will be contacted, the consenting ones will be recruited till target sample saturation. Afterwards, 40 healthy counterparts from each country will be selected. Healthy participants can be employees from Qassimi HospitaI in sharjah and Middle East Institute of Health University Hopsital in Lebanon or any healthy Emirati and Lebanese people willing to participate in the study.

You may qualify if:

• Emirati residing in UAE and Lebanese residing in Lebanon
• to 60 years old - from both genders
• Free of antibiotics for at least 3 months
• Two BMI categories: 1) obese with a BMI of ≥35 kg/m2 planning to undergo a bariatric procedure 2) healthy counterparts with a BMI of 18.5-24.9 kg/m2

You may not qualify if:

• Consumption of alcohol above the recommended amount per day (\>½ ounce of ethanol for females and \>1 ounce for men)
• Pregnant at the time of the study
• Significant voluntary weight loss (≥5% in the preceding 3 months)
• Not willing to provide written consent to the study

Sponsors & Collaborators

• Zayed University: lead

Study Sites (2)

Middle East Institute of Health, University Hospital

Beirut, Lebanon

NOT YET RECRUITING

Al Qassimi Hospital

Sharjah city, United Arab Emirates

RECRUITING

Related Publications (12)

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  BACKGROUND

• Damms-Machado A, Mitra S, Schollenberger AE, Kramer KM, Meile T, Konigsrainer A, Huson DH, Bischoff SC. Effects of surgical and dietary weight loss therapy for obesity on gut microbiota composition and nutrient absorption. Biomed Res Int. 2015;2015:806248. doi: 10.1155/2015/806248. Epub 2015 Feb 1.

  PMID: 25710027 BACKGROUND

• Cannon CP, Kumar A. Treatment of overweight and obesity: lifestyle, pharmacologic, and surgical options. Clin Cornerstone. 2009;9(4):55-68; discussion 69-71. doi: 10.1016/s1098-3597(09)80005-7.

  PMID: 19789064 RESULT

• Seganfredo FB, Blume CA, Moehlecke M, Giongo A, Casagrande DS, Spolidoro JVN, Padoin AV, Schaan BD, Mottin CC. Weight-loss interventions and gut microbiota changes in overweight and obese patients: a systematic review. Obes Rev. 2017 Aug;18(8):832-851. doi: 10.1111/obr.12541. Epub 2017 May 19.

  PMID: 28524627 RESULT

• Aydin S. Can Peptides and Gut Microbiota Be Involved in the Etiopathology of Obesity? Obes Surg. 2017 Jan;27(1):202-204. doi: 10.1007/s11695-016-2429-0. No abstract available.

  PMID: 27787759 RESULT

• Bauer PV, Hamr SC, Duca FA. Regulation of energy balance by a gut-brain axis and involvement of the gut microbiota. Cell Mol Life Sci. 2016 Feb;73(4):737-55. doi: 10.1007/s00018-015-2083-z. Epub 2015 Nov 5.

  PMID: 26542800 RESULT

• Cani PD, Osto M, Geurts L, Everard A. Involvement of gut microbiota in the development of low-grade inflammation and type 2 diabetes associated with obesity. Gut Microbes. 2012 Jul-Aug;3(4):279-88. doi: 10.4161/gmic.19625. Epub 2012 May 14.

  PMID: 22572877 RESULT

• Corfe BM, Harden CJ, Bull M, Garaiova I. The multifactorial interplay of diet, the microbiome and appetite control: current knowledge and future challenges. Proc Nutr Soc. 2015 Aug;74(3):235-44. doi: 10.1017/S0029665114001670. Epub 2015 Jan 23.

  PMID: 25612669 RESULT

• Patrone V, Vajana E, Minuti A, Callegari ML, Federico A, Loguercio C, Dallio M, Tolone S, Docimo L, Morelli L. Postoperative Changes in Fecal Bacterial Communities and Fermentation Products in Obese Patients Undergoing Bilio-Intestinal Bypass. Front Microbiol. 2016 Feb 23;7:200. doi: 10.3389/fmicb.2016.00200. eCollection 2016.

  PMID: 26941724 RESULT

• Round JL, Mazmanian SK. The gut microbiota shapes intestinal immune responses during health and disease. Nat Rev Immunol. 2009 May;9(5):313-23. doi: 10.1038/nri2515.

  PMID: 19343057 RESULT

• Adlerberth I, Wold AE. Establishment of the gut microbiota in Western infants. Acta Paediatr. 2009 Feb;98(2):229-38. doi: 10.1111/j.1651-2227.2008.01060.x.

  PMID: 19143664 RESULT

• Wilson MM, Thomas DR, Rubenstein LZ, Chibnall JT, Anderson S, Baxi A, Diebold MR, Morley JE. Appetite assessment: simple appetite questionnaire predicts weight loss in community-dwelling adults and nursing home residents. Am J Clin Nutr. 2005 Nov;82(5):1074-81. doi: 10.1093/ajcn/82.5.1074.

  PMID: 16280441 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Stool microbiota analysis (stool analysis): for healthy and for obese participants (pre and post bariatric intervention after 3 months). Using Polymerase Chain Reaction products of the V3-V4 region of 16S rRNA gene will be sequenced using a barcoded Illumina paired-end sequencing technique.

MeSH Terms

Conditions

Obesity; Dysbiosis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Mirey Karavetian, PhD

  Zayed University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirey karavetian, PhD

CONTACT

+971562446865; Mirey.Karavetian@zu.ac.ae

Manal Ali Ahmad, MS

CONTACT

+971529665962; manale.aa@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: December 16, 2019
• Study Start: October 27, 2019
• Primary Completion: May 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1); AE (1)