Adaptation of Human Gut Microbiota to Energetic Restriction

NCT01454232 | Completed

• 1 other identifier: P100111
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Gut microbiota ecology is altered in obesity and could link obesity and its complications. Bariatric surgery enables a major and sustained weight loss therefore improving obesity related disease. the investigators primary aim is to evaluate gut microbiota adaptation to weight loss and the specific role of energetic restriction. Furthermore we aim to compare gut flora of obese patients post bariatric surgery to that of lean healthy volunteers. Thus, the investigators plan to compare gut microbiota from 140 obese individuals before and after either restrictive (gastric banding) procedures or gastric bypass procedures to that of 40 lean healthy volunteers at baseline.

Conditions

Obesity; Metabolic Diseases; Nutrition Disorders; Body Weight

Keywords

Obesity; adipose tissue inflammation; Low grade systemic inflammation; gut microbiota; Bariatric surgery

Outcome Measures

Primary Outcomes (2)

• Analyse changes early, medium and long term changes in gut microbiota composition in a kinetic manner

  at 1, 3 and 12 months after surgery

• Compare gut microbiota kinetic changes in obese to gut microbiota healthy volunteers

  at 1, 3 and 12 months after surgery in the obese group and compare it to baseline in lean subjects

Secondary Outcomes (5)

• Establish early, medium and long term changes in insulin sensitivity and GLP1 secretion profile after oral glucose load and look for potential associations between these changes and gut microbiota composition

  1, 3 and 12 months after surgery

• Establish early, medium and long term changes in systemic and adipose tissue inflammation and look for potential associations between gut microbiota composition and inflammation modification

  1, 3 and 12 months after surgery

• Establish early, medium and long term changes in body composition and look for potential associations between these changes and gut microbiota modifications

  1, 3 and 12 months after surgery

• Establish early, medium and long term changes in nutritional blood sample concentrations and look for a potential association between gut microbiota modifications.

  1, 3, 12 months after surgery

• Establish early, medium and long term improvement in obesity related disease (reducing the number of treatments and the need for PPC use) and look for potential association with gut microbiota modification

  1, 3 and 12 months after surgery

Study Arms (2)

gastric surgery

OTHER

obese patients addressed for gastric surgery

Other: stools sampling; Other: adipose tissue biopsy

lean healthy subjects evaluated once

ACTIVE COMPARATOR

lean healthy subjects evaluated once

Other: stools sampling; Other: adipose tissue biopsy

Interventions

stools sampling OTHER

stools sampling at baseline, 1, 3 and 12 months

gastric surgery; lean healthy subjects evaluated once

adipose tissue biopsy OTHER

surgical adipose tissue biopsy during surgery, 1, 3 and 12 months

gastric surgery; lean healthy subjects evaluated once

Eligibility Criteria

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

You may qualify if:

• Obesity with BMI\> 40 kg/m² or obesity with BMI between 35 and 40 kg/M² with comorbidities (OSA, type 2 diabetes, hypertension etc…)
• Age: 18-65
• women
• weight stable for three months preceding surgery

You may not qualify if:

• Inflammatory disease
• Pregnancy
• Lactose intolerance
• Antibiotherapy in the three months preceding surgery
• cancer
• Drugs (AINS)
• Healthy group
• \<BMI\<25kg/m²
• Age: 18-65
• women
• non diabetic
• Inflammatory disease
• Pregnancy
• Antibiotherapy in the two months preceding the visit
• pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié Salpêtrière Hospital

Paris, 75013, France

Location

Related Publications (2)

• Torres L, Camila Goncalves Miranda M, Dantas Martins V, Caixeta F, de Almeida Oliveira M, Martins Trindade L, Carvalho de Assis H, Nascimento V, Pinheiro Rosa N, Gomes E, Oliveira Almeida S, Marquet F, Genser L, Marcelin G, Clement K, Russo M, Maria Caetano Faria A, Uceli Maioli T. Obesity-induced hyperglycemia impairs oral tolerance induction and aggravates food allergy. Mucosal Immunol. 2023 Aug;16(4):513-526. doi: 10.1016/j.mucimm.2023.05.008. Epub 2023 Jun 10.

  PMID: 37302712 DERIVED

• Aron-Wisnewsky J, Prifti E, Belda E, Ichou F, Kayser BD, Dao MC, Verger EO, Hedjazi L, Bouillot JL, Chevallier JM, Pons N, Le Chatelier E, Levenez F, Ehrlich SD, Dore J, Zucker JD, Clement K. Major microbiota dysbiosis in severe obesity: fate after bariatric surgery. Gut. 2019 Jan;68(1):70-82. doi: 10.1136/gutjnl-2018-316103. Epub 2018 Jun 13.

  PMID: 29899081 DERIVED

MeSH Terms

Conditions

Obesity; Metabolic Diseases; Nutrition Disorders; Body Weight

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karine Clement, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 18, 2011
• Study Start: June 7, 2011
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

FR (1)