Status:
NOT_YET_RECRUITING
Gut Microbiota, Diet-INDuced Obesity and Type 2 Diabetes in New Caledonia - MIND
Lead Sponsor:
Institut Pasteur
Collaborating Sponsors:
RIKEN Center for Integrative Medical Sciences
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
18+ years
Brief Summary
In recent years, the global rise in obesity and type 2 diabetes has become a major public health issue. In New Caledonia, 38% of the adult population has a body mass index ≥30. At the same time, the p...
Detailed Description
The goal of the study is to describe and characterize the gut microbiota and fecal metabolome of participants and study the relationships between microbiota composition and bioclinical parameters in p...
Eligibility Criteria
Inclusion
- Aged between 18 and 60 years.
- Ability to understand and provide informed consent.
- Ability and willingness to meet the required schedule and study interventions.
- Willingness to share their community belonging
- Benefit from a social security system.
- For obese and diabetic patients :
- IMC ≥ 30 kg/m² with type 2 diabetes
- Fasting plasma glucose (FPG) ≥7 mM (=1.26g/l) or
- Patients with HbA1c ≥ 6.5% (48 mmol/mol)
- All stages of albuminuria For obese patients without type 2 diabetes
- IMC ≥ 30 kg/m²
- Weight stable for at least 2 months
- Patients with normal glucose tolerance (NGT), impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG) and an HbA1c \< 6.5 %
- No treatment (diabetic or weight loss)
- Match age (±5years), sex and self-reported community to the patients from the1 group.
- For control group :
- BMI between 18.5-24.9 kg/m²
- Match age (±5years), sex and self-reported community to the patients from the 1 and 2 groups.
- Participants with normal glucose tolerance (NGT), impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG) and an HbA1c \< 6.5 %
Exclusion
- All participants :
- Treatment that may alter gastrointestinal motor function, acidity, microbial population, or immunosuppressants
- Altered anatomy of the esophagus, stomach, small intestine, or large intestine due to gastrointestinal surgery (except appendectomy or cholecystectomy)
- Chronic or acute inflammatory bowel disease or infections
- Abdominal or pelvic radiation therapy or abdominal cancer, colorectal cancer
- Dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorders
- Organ transplantation and patients receiving immunosuppressive therapy
- Severe renal failure and/or patients undergoing dialysis
- Cardiovascular, endocrine, renal, or other chronic disease that may affect motility.
- Preparation for colon cleansing within the last month
- \< 3 bowel movements per week
- Women who are pregnant or breastfeeding
Key Trial Info
Start Date :
November 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT07205913
Start Date
November 15 2025
End Date
November 15 2026
Last Update
October 3 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.