Effect of MEDiterranean Diet on the microBIOME of Individuals With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in HOMA-IR from baseline to visit 2 and 3
研究概览
简要总结
Dysbiosis of gut microbiota is associated with the pathophysiology of type 2 diabetes. Mediterranean diet has been indicated as a dietary pattern that promote the integrity of gut barrier and that has positive impact in the metabolic control of subjects with type 2 diabetes. This is a 12-week, single-arm clinical study that aims to evaluate if the effect of Mediterranean diet in metabolic control of these subjects is mediated by gut microbiota. Subjects will receive personalized nutrition counseling where Mediterranean diet will be promoted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria;
- •Ages 40-80 years;
- •Non-smoker;
- •Willing and able to provide written informed consent.
排除标准
- •Diabetes diagnosed before 40 years old;
- •Changes in oral glycaemic-control medications in the last 3 months;
- •Subjects with HbA1c levels under 6.4% or above 10%;
- •Subjects under insulinotherapy;
- •Subjects under corticotherapy;
- •Subjects with triglycerides levels above 4.52 nmol/L (400 mg/dL);
- •Intake of antibiotics in the last 12 weeks;
- •Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS.
结局指标
主要结局
Changes in HOMA-IR from baseline to visit 2 and 3
时间窗: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in intestinal microbiota from baseline to visit 2 and 3
时间窗: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2) and 12-week post Mediterranean diet intervention (visit 3)
Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage
Changes in fasting insulin (μU/mL) levels from baseline to visit 2 and 3
时间窗: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in HbA1c levels (percent) from baseline to visit 2 and 3
时间窗: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in HOMA-B (percent) from baseline to visit 2 and 3
时间窗: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in HOMA-S (percent) from baseline to visit 2 and 3
时间窗: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in fasting capillary blood glucose (mg/dL) from baseline to visit 2 and 3
时间窗: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
次要结局
- Changes in free fat mass (kg) from baseline to visit 2 and 3(1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3))
- Changes in total body fat mass (kg) from baseline to visit 2 and 3(1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3))
- Changes in diet quality from baseline to visit 3(1-week post run-in period (baseline), 12-week post Mediterranean diet intervention (visit 3))
- Changes in food intake from baseline to visit 2 and 3(1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3))
- Changes in fasting serum total cholesterol (mg/dL) from baseline to visit 2 and 3(1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3))
- Changes in fasting serum low-density lipoprotein (LDL) (mg/dL) cholesterol from baseline to visit 2 and 3(1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3))
- Changes in fasting serum triglycerides (mg/dL) from baseline to visit 2 and 3(1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3))
- Changes in fasting serum high-density lipoprotein (HDL) (mg/dL) cholesterol from baseline to visit 2 and 3(1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3))
- Changes in waist perimeter (cm) from baseline to visit 2 and 3(1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3))