Adaptation of Human Gut Microbiota to Energetic Restriction (microbaria)
| Tracking Information | |||||
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| First Received Date ICMJE | October 7, 2011 | ||||
| Last Updated Date | October 30, 2012 | ||||
| Start Date ICMJE | June 2011 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01454232 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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. Thus, the investigators plan to compare gut microbiota from 70 obese individuals before and after either restrictive (gastric banding)procedures or gastric bypass procedures. |
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| 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. 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 35 obese patients addressed for gastric banding and 35 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. 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 |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | gastric surgery
obese patients addressed for gastric surgery
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 70 | ||||
| Estimated Completion Date | June 2014 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria :
Exclusion criteria :
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| Gender | Female | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01454232 | ||||
| Other Study ID Numbers ICMJE | P100111 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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