Gut Microbiota, Diet-INDuced Obesity and Type 2 Diabetes in New Caledonia - MIND
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 270
- 主要终点
- Describe and characterise the faecal microbiota of patients to investigate the relationships between microbiota composition with bioclinical parameters
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 %
排除标准
- •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
研究组 & 干预措施
Control group of participants considered as "metabolically healthy"
干预措施: Urine sample (Other)
Control group of participants considered as "metabolically healthy"
干预措施: Stools (Other)
Control group of participants considered as "metabolically healthy"
干预措施: 40 ml blood sample (Other)
Obese group with a BMI ≥30 with type 2 diabetes
干预措施: 25 ml blood sample (Other)
Obese group with a BMI ≥30 with type 2 diabetes
干预措施: Urine sample (Other)
Obese group with a BMI ≥30 with type 2 diabetes
干预措施: Stools (Other)
Obese group with a BMI ≥30 without any type of diabetes
干预措施: 25 ml blood sample (Other)
Obese group with a BMI ≥30 without any type of diabetes
干预措施: Urine sample (Other)
Obese group with a BMI ≥30 without any type of diabetes
干预措施: Stools (Other)
结局指标
主要结局
Describe and characterise the faecal microbiota of patients to investigate the relationships between microbiota composition with bioclinical parameters
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点