Status:
COMPLETED
Jejunal Luminal and Colonic Mucosa-Associated Microbiota in Metabolic Diseases: Methods, Identification and Causalities
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Diabetes Mellitus
Obesity
Eligibility:
All Genders
18-60 years
Brief Summary
This clinical study will investigate Jejunal Microbiota in Metabolic Diseases (Je-MiMe, n=45) and Colonic mucosa-associated Microbiota in Metabolic Diseases (Col-MiMe, n=45). Each cohort (Je and Col ...
Eligibility Criteria
Inclusion
- General
- Aged between 18 and 60 years;
- Ability to understand and provide informed consent (in French);
- Ability and willingness to meet the required schedule and study procedures;
- Group-Specific
- Control Group
- Inclusion criteria for the participants from the Control group are:
- Presence of Gastroesophageal Reflux Disease symptoms or gastric discomfort.
- BMI \[19kg/m² \< BMI \<25 kg/m²\]
- Match age and sex to the patients from the Ob and ObD groups.
- Only patients with normal glucose tolerance (NGT), glucose tolerance (IGT) and/or fasting glucose (IFG) and an HbA1c \< 6.5 % will be included in this group.
- Ob Group
- Inclusion criteria for the participants from Ob and ObD groups are:
- ● Candidate for bariatric surgery and meet the HAS criteria (Haute Autorité de Santé, 2009) :
- IMC ≥ 40 kg/m² without comorbidities Or IMC≥ 35 kg/m² with at least one obesity-related comorbidity (i.e.: Hypertension, Dyslipidemia, Obstructive Sleep Apnea, Joints Disease, non-alcoholic steatohepatitis, excluding T2D)
- Weight stable for at least 2 months
- No treatment for metabolic health complications, no previous obesity surgery, no obesity treatment drug.
- No monogenic form of obesity (Hebebrand et al., 2017)
- ObD Group
- Inclusion criteria for the participants from ObD groups are:
- Candidate for bariatric surgery with T2D
- At least one obesity-related comorbidity including T2D
- Fasting plasma glucose (FPG) ≥7 mM (=1.26g/l) or
- Participants with HbA1c ≥ 6.5% (48 mmol/mol)
- All stages of albuminuria
Exclusion
- General Non-inclusion Criteria:
- Treatment for the previous 12 week that could
- alter gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics, laxatives),
- acidity (PPI, H2RA)
- microbial population (e.g.: antibiotics, probiotics)
- immunosuppressants (eg: calcineurin inhibitors, corticosteroids, biological agents, etc.).
- use of weight-loss drug or dietary intervention aiming to lose weight;
- Altered anatomy of the esophagus, stomach, small or large intestine due to prior gastrointestinal surgery (exceptions include appendectomy or cholecystectomy more than 3 months prior to enrollment) or other reasons;
- Any abdominal or pelvic surgery within the past 3 months;
- Diverticulitis, diverticular stricture, or other intestinal strictures.
- Intestinal resection of the gastrointestinal tract
- Previous history of gastric bezoar or gastroparesis
- Acute or chronic inflammatory bowel disease or infections diseases (i.e.: VHC, VHB, VIH, etc.)
- Abdominal or pelvic radiotherapy or abdominal cancer
- Colorectal cancer, either known or not
- Dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder
- Organ Transplantation and patients on Immunosuppressive Therapy
- Severe kidney failure and/or patients on dialysis therapy (serum creatinine \> 150 μmol/l or eGFR \< 60 ml/min per 1.73 m2 body surface area)
- CVD, endocrine, renal or other chronic disease likely to affect motility.
- Colon cleansing preparation during the last 1 month
- No \< 3 bowel movements per week
- Females of childbearing age who do not practice birth control and/or are pregnant or lactating
- Participants non-affiliated to the French national health scheme
- Participants who are already included in a clinical study which implies testing any pharmaceutical drug.
- Participants who do not understand the research procedures those who are institutionalized, or who unable to give informed consent
- Participants placed under legal protection
- Patients with drug addiction
- Antibiotherapy 3 months preceding the endoscopy
- Weight variation (diminution or increase) \> 5kg in the last 3 months
- Specific non-inclusion Criteria
- Ob and ObT2D Group
- Usual contraindication for bariatric surgery;
Key Trial Info
Start Date :
January 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 17 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05186389
Start Date
January 17 2022
End Date
January 17 2024
Last Update
September 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Privé des Peupliers, 8 Place de l'Abbé Georges Hénocque, 75013
Paris, France