Jejunal Luminal and Colonic Mucosa-Associated Microbiota in Metabolic Diseases: Methods, Identification and Causalities

Launched by INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE, FRANCE · Jan 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the role of gut bacteria in people with obesity and type 2 diabetes, focusing on two parts: one looks at the bacteria in the small intestine (jejunum), and the other examines the bacteria in the colon. The research will involve 90 adult participants, divided into three groups: those with a healthy weight, those with obesity, and those with both obesity and type 2 diabetes. Researchers will collect samples during routine endoscopy or colonoscopy procedures to compare different types of gut bacteria and understand how they relate to metabolic health and inflammation.

To be eligible for this study, participants need to be between 18 and 60 years old and able to understand the study's procedures. People with obesity who are considering weight-loss surgery or those with type 2 diabetes may qualify, while individuals with certain health conditions or who have taken specific medications recently may not be eligible. Participants can expect to contribute to important research that could lead to better treatments for metabolic diseases, while being closely monitored throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * General Inclusion Criteria:
• • 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 Inclusion Criteria:
• • 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 Criteria:
• * 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;