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

NCT07205913 | Not Yet Recruiting

• 2 other identifiers: 2025-0202025-A01257-42
• Study Type: observational
• Target: 270
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Diabetes Mellitus, Type 2; Obesity

Keywords

microbiota; New Caledonia; metabolic diseases

Outcome Measures

Primary Outcomes (2)

• 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

  6 years

• 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.

  6 years

Study Arms (3)

Obese group with a BMI ≥30 with type 2 diabetes

Other: 25 ml blood sample; Other: Urine sample; Other: Stools

Obese group with a BMI ≥30 without any type of diabetes

Other: 25 ml blood sample; Other: Urine sample; Other: Stools

Control group of participants considered as "metabolically healthy"

Other: Urine sample; Other: Stools; Other: 40 ml blood sample

Interventions

25 ml blood sample OTHER

A 25-ml blood sample

Obese group with a BMI ≥30 with type 2 diabetes; Obese group with a BMI ≥30 without any type of diabetes

Urine sample OTHER

A 10-ml urine sample

Control group of participants considered as "metabolically healthy"; Obese group with a BMI ≥30 with type 2 diabetes; Obese group with a BMI ≥30 without any type of diabetes

Stools OTHER

10-g stools

Control group of participants considered as "metabolically healthy"; Obese group with a BMI ≥30 with type 2 diabetes; Obese group with a BMI ≥30 without any type of diabetes

40 ml blood sample OTHER

A 40-ml blood sample

Control group of participants considered as "metabolically healthy"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults living in New Caledonia who are obese with or without type 2 diabetes or healthy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur: lead
• RIKEN Center for Integrative Medical Sciences: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample Urine stools

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Metabolic Diseases

Interventions

Blood Specimen Collection; Defecation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: March 9, 2026

Record last verified: 2025-09