Gut Microbiota, Diet-INDuced Obesity and Type 2 Diabetes in New Caledonia - MIND

Pasteur Institute

Status

Not yet enrolling

Conditions

Obesity

Diabetes Mellitus, Type 2

Treatments

Other: Urine sample

Other: 25 ml blood sample

Other: 40 ml blood sample

Other: Stools

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT07205913

2025-020

2025-A01257-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 participants with different metabolic states, ranging from "metabolically healthy" to severe obesity with and without type 2 diabetes.

To achieve this goal, adults in New Caledonia divided in 3 groups

Obese group with a BMI ≥ 30 with type 2 diabetes,
Obese group with a BMI ≥ 30 without any type of diabetes,
Control group of participants with a BMI between 18.5 and 24.9 kg/m2 and without any type of diabetes.

will be recruited. Blood, urine, and stool samples will be collected from participants. A questionnaire to collect sociodemographic characteristics as well as behaviors and lifestyle habits related to diet, physical activity, and psychological health.

Enrollment

270 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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