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

NCT05186389 | Completed DMC

• 1 other identifier: C20-86
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 -MiMe) is composed of three groups: participants with obesity (n=15) with obesity and with type II diabetes (n=15). This research protocol is organized in two parts. Each part of this study will recruit 45 participants that are only recruited in one of the parts of the protocol (JE-MIME or COL-MIME). Thus, in total, the study will include 90 patients. Each part of this study is composed of 3 groups: 1) "Control Group ", 2) Obese group (Ob), 3) Obese and Type 2 Diabetes group (ObD). Control groups for part I (JE-MIME) and part 2 (COL-MIME) are composed of different participants. Each group is composed of 15 human adult volunteers for the JE-MIME study (part 1) and 15 participants for the COL-MIME study (part 2). Total number of participants is 45 for part 1, and 45 for part 2. Total number for this project is 90. Microbiota wil be collected during an endoscopy or coloscopy which is planned as routine care for the patients. Primary objectives are to characterize jejunal (JE-MIME, Part I of the study) and colonic mucosa-associated microbiota (COLMIME, Part II of the study) and compare both microbiota to faecal microbiota (evaluate differences and similarities between jejunal microbiota or mucus-associated microbiota and faecal microbiota). Secondary objectives are to 1) Correlate microbiota with metabolic health and inflammatory markers; 2) Correlate microbiota with lifestyle and neuropsychological health. Both the jejunal microbiota and mucus-associated microbiota are strong integrators of nutritional environment and intestinal health status, respectively, compared to the fecal microbiota. This study will help to better understand the physiopathology of metabolic diseases. This research could lead to finding specific microbiota members, either from the jejunal compartment or from the inner mucus layer, crucial for the promotion / protection of chronic intestinal inflammation and associated metabolic health.

Conditions

Diabetes Mellitus; Obesity; Metabolic Disease

Keywords

microbiota; endoscopy; colonoscopy; obesity; type II diabetes

Outcome Measures

Primary Outcomes (1)

• Metagenomic analysis

  Single time point analysis of jejunal or colonic mucosal-associated and fecal microbiota. Microbiota will be analysed through 16S rRNA gene sequencing as well as shotgun metagenomic sequencing of the different samples. We will examine if jejunal microbiota abundance is decreased in subjects with obesity and obesity + type 2 diabetics compared to lean subjects. Based on metagenomic sequencing data, the number of bacterial genes will be estimated and compared between groups. We will examine the distance of bacterial layer in the mucus from intestinal epithelial cells in people with T2D as compared to people without T2D and lean subjects.

  1 month

Secondary Outcomes (1)

• Clinical associations with metagenomic analysis

  1 month

Study Arms (3)

"Control Group"

15 non-obese participants considered "metabolically-healthy" : "control group"

Obese group (Ob)

15 severely obese participants, candidates for bariatric surgery, but without T2D: "obese group" (Ob)

Obese and Type 2 Diabetes group (ObD)

15 participants who are both severely obese, candidates for bariatric surgergy and diagnosed with T2D: "obese and diabetic group" (ObD).

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

1. Control Group 15 non-obese participants considered "metabolically-healthy" : "control group" 2. Obese group (Ob) 15 severely obese participants, candidates for bariatric surgery, but without T2D: "obese group" (Ob) 3. Obese and Type 2 Diabetes group (ObD) 15 participants who are both severely obese, candidates for bariatric surgergy and diagnosed with T2D: "obese and diabetic group" (ObD).

You may qualify if:

• 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;
• Control Group
• 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
• ● 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Hôpital Privé des Peupliers, 8 Place de l'Abbé Georges Hénocque, 75013

Paris, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, urines, blood, jejunal fluid, jejunal biopsies, colonic biopsies.

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Metabolic Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 11, 2022
• Study Start: January 17, 2022
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: September 19, 2025

Record last verified: 2025-01

Locations

FR (1)