Diabetes MellitusJE/COL-MIMENCT05186389
Jejunal Luminal and Colonic Mucosa-Associated Microbiota in Metabolic Diseases: Methods, Identification and Causalities
An observational study of Diabetes Mellitus and Obesity, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Obesity, Metabolic Disease
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2022to 17 Jan 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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
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- 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
Who cannot join
- 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.).
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- 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;
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Privé des Peupliers, 8 Place de l'Abbé Georges Hénocque, 75013
Paris
About this study
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).
Read more
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
- Medical subject headings
- Diabetes Mellitus, Obesity, Metabolic Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| "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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
Clinical associations with metagenomic analysis
Single time point analysis : Investigation of the correlations between jejunal microbiota or mucosal-associated microbiota and clinical parameters.
Secondary objectives are to analyse the relationship between jejunal microbiota/mucus-associated microbiota and metabolic health, inflammation, lifestyle and mental health that will be evaluated through extensive bio-clinical phenotyping and will include:
- Metabolic phenotype (serum)
- Systemic inflammation status and Entero and Neuroendocrine markers (serum and biopsies)
- Anthropometric measurements
- Histological analysis of the jejunal biopsy obtained during endoscopy and colonoscopy
- Lifestyle factors collected through lifestyle questionnaires:
- Medical history questionnaires
- Dietary patterns
- Physical activity
- Smoking habits
- Psycho-emotional health and Quality of Life
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start17 Jan 2022
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186389
- Sponsor's protocol ID
- C20-86
- Acronym
- JE/COL-MIME
- Status last verified
- Jan 2025
- First submitted
- 7 Dec 2021
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Steinbach E, Belda E, Alili R, Adriouch S, Dauriat CJG, Donatelli G, Dumont JL, Pacini F, Tuszynski T, Pelloux V, Jacques F, Creusot L, Coles E, Taillandier P, Vazquez Gomez M, Masi D, Mateo V, Andre S, Kordahi M, Rouault C, Zucker JD, Sokol H, Genser L, Chassaing B, Le Roy T, Clement K. Comparative analysis of the duodenojejunal microbiome with the oral and fecal microbiomes reveals its stronger association with obesity and nutrition. Gut Microbes. 2024 Jan-Dec;16(1):2405547. doi: 10.1080/19490976.2024.2405547. Epub 2024 Oct 7.
PubMed 39679619