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Adaptation of Human Gut Microbiota to Energetic Restriction (microbaria)

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ClinicalTrials.gov Identifier: NCT01454232
Recruitment Status : Completed
First Posted : October 18, 2011
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE October 7, 2011
First Posted Date  ICMJE October 18, 2011
Last Update Posted Date March 15, 2019
Actual Study Start Date  ICMJE June 7, 2011
Actual Primary Completion Date September 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • Analyse changes early, medium and long term changes in gut microbiota composition in a kinetic manner [ Time Frame: at 1, 3 and 12 months after surgery ]
  • Compare gut microbiota kinetic changes in obese to gut microbiota healthy volunteers [ Time Frame: at 1, 3 and 12 months after surgery in the obese group and compare it to baseline in lean subjects ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2011)
Analyse changes early, medium and long term changes in gut microbiota composition in a kinetic manner [ Time Frame: at 1, 3 and 12 months after surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2011)
  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 1, 3 and 12 months after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adaptation of Human Gut Microbiota to Energetic Restriction
Official Title  ICMJE Modification of Human Gut Microbiota in Massive Obesity After Bariatric Surgery: the Role of Energetic Restriction
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.

Detailed Description

The prevalence of obesity is rising to an epidemic level. Yet medical and pharmacological treatments have proven their limits. Dietetic modifications contribute to adipose tissue alterations and cross talk dysfunction with other tissues linked to weight maintenance. In a previous study in a model of abrupt weight loss 6 months after Roux-en-Y Bypass, the investigators observed a rapid adaptation of the dominant gut microbiota. Conversely some species were directly linked to the improvement of low grade inflammation independently of calory intake.

Therefore the investigators hypothesized that gut microbiota in obese patients could link food consumption with obesity alterations such as metabolic impairments, energetic storage dysfunction and increased systemic and adipose tissue inflammation.

The investigators want to address the specific role of energetic restriction in gut microbiota modification after weight loss.

To answer that question the investigators will evaluate gut microbiota composition before and during the first year after either gastric banding or gastric bypass surgery. they also aim to evaluate whether gut flora post surgery evolves toward that of lean healthy subjects Our study has several objectives. The investigators also aim to assess whether gut microbiota modification is associated with systemic and tissue inflammation reduction and metabolic improvement during the follow up.

This project is based on a clinical protocol performed in massively obese subjects (BMI>40 kg/m²). The investigators plan to recruit 70 obese patients addressed for gastric banding and 70 candidates for gastric bypass. Clinical phenotype, biochemical analysis, body composition, systemic and adipose tissue inflammation, endotoxemia and gut microbiota will be assessed at baseline and 1, 3 and 12 months after surgery. Specific food consumption will be recorded at every time point. A group of 40 lean healthy volunteers will undergo the same phenotyping.

Associations between all these clinical and biological parameters will be assessed at the different point of the follow up.

More generally, this project might lead us to elucidate a new function of gut microbiota and eventually consider novels anti obesity therapeutic strategies

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Obesity
  • Metabolic Diseases
  • Nutrition Disorders
  • Body Weight
Intervention  ICMJE
  • Other: stools sampling
    stools sampling at baseline, 1, 3 and 12 months
  • Other: adipose tissue biopsy
    surgical adipose tissue biopsy during surgery, 1, 3 and 12 months
Study Arms  ICMJE
  • gastric surgery
    obese patients addressed for gastric surgery
    Interventions:
    • Other: stools sampling
    • Other: adipose tissue biopsy
  • Active Comparator: lean healthy subjects evaluated once
    lean healthy subjects evaluated once
    Interventions:
    • Other: stools sampling
    • Other: adipose tissue biopsy
Publications * 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, Clément 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2017)
140
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2011)
70
Actual Study Completion Date  ICMJE September 14, 2018
Actual Primary Completion Date September 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Obese group

Inclusion criteria :

  • 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

Exclusion criteria :

  • Inflammatory disease
  • Pregnancy
  • Lactose intolerance
  • Antibiotherapy in the three months preceding surgery
  • cancer
  • Drugs (AINS)

Healthy group

Inclusion criteria :

  • 19<BMI<25kg/m²
  • Age: 18-65
  • women
  • non diabetic

Exclusion criteria :

  • Inflammatory disease
  • Pregnancy
  • Antibiotherapy in the two months preceding the visit
  • pregnancy
  • Drugs (AINS) in the 48h preceding the visit
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01454232
Other Study ID Numbers  ICMJE P100111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karine Clement, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP