ObesitymicrobariaNCT01454232
Adaptation of Human Gut Microbiota to Energetic Restriction
A study testing stools sampling and adipose tissue biopsy in people with Obesity and Metabolic Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Diseases, Nutrition Disorders
- What is being tested?
- stools sampling and adipose tissue biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2011to 14 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 19<BMI<25kg/m²
- Age: 18-65
- women
- non diabetic
Who cannot join
- Inflammatory disease
- Pregnancy
- Lactose intolerance
- Antibiotherapy in the three months preceding surgery
- cancer
- Drugs (AINS)
Show all 12Show fewer
- Healthy group
- Inflammatory disease
- Pregnancy
- Antibiotherapy in the two months preceding the visit
- pregnancy
- Drugs (AINS) in the 48h preceding the visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modification of Human Gut Microbiota in Massive Obesity After Bariatric Surgery: the Role of Energetic Restriction
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.
Read the 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
- Conditions
- Obesity, Metabolic Diseases, Nutrition Disorders, Body Weight
- Being tested
- stools sampling, adipose tissue biopsy
- Keywords
- Obesity, adipose tissue inflammation, Low grade systemic inflammation, gut microbiota, Bariatric surgery
- Medical subject headings
- Obesity, Metabolic Diseases, Nutrition Disorders, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stools samplingOther
stools sampling at baseline, 1, 3 and 12 months
adipose tissue biopsyOther
surgical adipose tissue biopsy during surgery, 1, 3 and 12 months
| Study group | Role | What they receive |
|---|---|---|
| gastric surgery | Other | obese patients addressed for gastric surgery Receives: Other: stools sampling; Other: adipose tissue biopsy |
| lean healthy subjects evaluated once | Active comparator | lean healthy subjects evaluated once Receives: Other: stools sampling; Other: adipose tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyse changes early, medium and long term changes in gut microbiota composition in a kinetic manner
Measured: at 1, 3 and 12 months after surgery
Compare gut microbiota kinetic changes in obese to gut microbiota healthy volunteers
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 1, 3 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study start7 Jun 2011
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine Clement, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454232
- Sponsor's protocol ID
- P100111
- Acronym
- microbaria
- Status last verified
- Mar 2019
- First submitted
- 7 Oct 2011
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37302712Aron-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.
PubMed 29899081
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Human Gut Microbiota in Massive Obesity After Bariatric Surgery: the Role of Energetic Restriction
- ClinicalTrials.gov ID
- NCT01454232
- Acronym / sponsor ID
- microbaria / P100111
- Conditions
- Obesity, Metabolic Diseases, Nutrition Disorders, Body Weight
- Keywords
- Obesity, adipose tissue inflammation, Low grade systemic inflammation, gut microbiota, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Jun 2011 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 18 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastric surgery | Other | Other: stools sampling, Other: adipose tissue biopsyobese patients addressed for gastric surgery |
| lean healthy subjects evaluated once | Active comparator | Other: stools sampling, Other: adipose tissue biopsylean healthy subjects evaluated once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 19<BMI<25kg/m²
Key exclusion criteria (12 listed)
- Inflammatory disease
- Pregnancy
- Lactose intolerance
- Antibiotherapy in the three months preceding surgery
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stools samplingstools sampling at baseline, 1, 3 and 12 months | Other | gastric surgery, lean healthy subjects evaluated once |
| adipose tissue biopsysurgical adipose tissue biopsy during surgery, 1, 3 and 12 months | Other | gastric surgery, lean healthy subjects evaluated once |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Derived from this study: PubMed 37302712Torres 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.
- Derived from this study: PubMed 29899081Aron-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine Clement, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stools sampling and adipose tissue biopsy in people with Obesity and Metabolic Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01454232, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.