Gut Microbiota, Diet-INDuced Obesity and Type 2 Diabetes in New Caledonia - MIND
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Pasteur
About this trial
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 prevalence of type 2 diabetes continues to rise steadily. The burden of these diseases does not affect communities uniformly. While known factors such as diet, physical activity, and socioeconomic conditions play a role, studies have demonstrated the involvement of the gut microbiota in the development of metabolic disorders, particularly obesity and insulin resistance. However, this area remains largely unexplored in New Caledonia and the Pacific.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adults living in New Caledonia who are obese with or without type 2 diabetes or healthy
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
25 ml blood sample
Other interventionA 25-ml blood sample
Urine sample
Other interventionA 10-ml urine sample
Stools
Other intervention10-g stools
40 ml blood sample
Other interventionA 40-ml blood sample
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: Obese group with a BMI ≥30 with type 2 diabetes3 interventions
Group B: Obese group with a BMI ≥30 without any type of diabetes3 interventions
Group C: Control group of participants considered as "metabolically healthy"3 interventions
Trial outcomes
Primary outcomes
1
Describe and characterise the faecal microbiota of patients to investigate the relationships between microbiota composition with bioclinical parameters
Microbiota will be analysed through 16S rRNA gene sequencing as well as shotgun metagenomic sequencing of the different samples obtained from the faecal sample
Time frame
6 years2
Describe and characterise the faecal microbiota and metabolome of patients to investigate the relationships between microbiota composition with bioclinical parameters
microbiome and metabolites from collected human fecal samples will be analyzed using a standardized extraction protocol designed for Liquid chromatography-mass spectrometry (LC/MS)-based metabolomics to detect short-chain fatty acids and bile acids,…. which are mainly produced by bacteriasequencing of the different samples obtained from the faecal sample.
Time frame
6 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut Pasteur
Lead sponsor
RIKEN Center for Integrative Medical Sciences
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: