Adaptation of Human Gut Microbiota to Energetic Restriction (microbaria)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01454232
First received: October 7, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Obesity
Metabolic Diseases
Nutrition Disorders
Body Weight
Other: stools sampling
Other: adipose tissue biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Modification of Human Gut Microbiota in Massive Obesity After Bariatric Surgery: the Role of Energetic Restriction

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: June 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
gastric surgery
obese patients addressed for gastric surgery
Other: stools sampling
stools sampling at baseline, 1, 3 and 12 months
Other Name: stools sampling
Other: adipose tissue biopsy
surgical adipose tissue biopsy during surgery, 1, 3 and 12 months
Other Name: adipose tissue biopsy
Active Comparator: lean healthy subjects evaluated once
lean healthy subjects evaluated once
Other: stools sampling
stools sampling at baseline, 1, 3 and 12 months
Other Name: stools sampling
Other: adipose tissue biopsy
surgical adipose tissue biopsy during surgery, 1, 3 and 12 months
Other Name: adipose tissue biopsy

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454232

Contacts
Contact: Karine Clement, MD, PhD 033 1 42 17 70 31 karine.clement@psl.aphp.fr

Locations
France
Pitié Salpêtrière Hospital Recruiting
Paris, France, 75013
Principal Investigator: Karine Clement, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Karine Clement, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01454232     History of Changes
Other Study ID Numbers: P100111
Study First Received: October 7, 2011
Last Updated: June 13, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Obesity
adipose tissue inflammation
Low grade systemic inflammation
gut microbiota
Bariatric surgery

Additional relevant MeSH terms:
Obesity
Body Weight
Metabolic Diseases
Nutrition Disorders
Malnutrition
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014