Diabetes Mellitus, Type 2MINDNCT07205913
Gut Microbiota, Diet-INDuced Obesity and Type 2 Diabetes in New Caledonia - MIND
An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Institut Pasteur.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- 25 ml blood sample, Urine sample and Stools
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults living in New Caledonia who are obese with or without type 2 diabetes or healthy
Who may be able to join
- 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 :
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- 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 %
Who cannot join
- 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
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- 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
About this study
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.
Read the 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 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.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- 25 ml blood sample, Urine sample, Stools, 40 ml blood sample
- Keywords
- microbiota, New Caledonia, metabolic diseases
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 ml blood sampleOther
A 25-ml blood sample
Urine sampleOther
A 10-ml urine sample
StoolsOther
10-g stools
40 ml blood sampleOther
A 40-ml blood sample
| Study group | Role | What they receive |
|---|---|---|
| Obese group with a BMI ≥30 with type 2 diabetes | Not described Receives: Other: 25 ml blood sample; Other: Urine sample; Other: Stools | |
| Obese group with a BMI ≥30 without any type of diabetes | Not described Receives: Other: 25 ml blood sample; Other: Urine sample; Other: Stools | |
| Control group of participants considered as "metabolically healthy" | Not described Receives: Other: Urine sample; Other: Stools; Other: 40 ml blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start15 Feb 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Institut PasteurThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RIKEN Center for Integrative Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205913
- Sponsor's protocol ID
- 2025-020
- Other IDs
- 2025-A01257-42
- Acronym
- MIND
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota, Diet-INDuced Obesity and Type 2 Diabetes in New Caledonia - MIND
- ClinicalTrials.gov ID
- NCT07205913
- Acronym / sponsor ID
- MIND / 2025-020
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- microbiota, New Caledonia, metabolic diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- RIKEN Center for Integrative Medical Sciences
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults living in New Caledonia who are obese with or without type 2 diabetes or healthy
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25 ml blood sampleA 25-ml blood sample | Other | Obese group with a BMI ≥30 with type 2 diabetes, Obese group with a BMI ≥30 without any type of diabetes |
| Urine sampleA 10-ml urine sample | Other | 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 |
| Stools10-g stools | Other | 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 sampleA 40-ml blood sample | Other | Control group of participants considered as "metabolically healthy" |
Primary outcome
Describe and characterise the faecal microbiota of patients to investigate the relationships between microbiota composition with bioclinical parameters
Time frame: 6 years
Microbiota will be analysed through 16S rRNA gene sequencing as well as shotgun metagenomic sequencing of the different samples obtained from the faecal sample
Describe and characterise the faecal microbiota and metabolome of patients to investigate the relationships between microbiota composition with bioclinical parameters
Time frame: 6 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Institut Pasteur.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe and characterise the faecal microbiota of patients to investigate the relationships between microbiota composition with bioclinical parameters (time frame: 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.