NCT03557541已完成不适用
Sardine-enriched Diet for Prevention Type 2 Diabetes in Elderly and Prediabetic Population
Institut d'Investigacions Biomèdiques August Pi i Sunyer2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2014年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- type 2 diabetes new onset
研究概览
简要总结
The hypothesis formulated is that 200 g of sardine on a weekly basis will have a favourable impact avoiding the natural development of the pathology due to changes in the biochemical profile, the anthropometrics, inflammatory markers, changes in gut microbiota populations, also in transcriptomics and metabolomics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •glycaemia between 100-125 md / dL or ≥5.7% HbA1c
排除标准
- •treatment with oral antidiabetic drugs
- •any nutritional education to prevent T2D
- •Suspect or known hypersensitivity to sardine or related fish
- •Chronic treatment with oral steroids and / or AINES
- •Treatment with oral antidiabetic agents and / or insulin
- •Treatment with immunosuppressive drugs
- •Diagnosis of active neoplasm
- •Diagnosis of HIV or AIDS
- •Abnormal liver profile (> 6 times normal values)
- •Diagnosis of Acute Psychiatric Sdr
- •Presence of serious acute concomitant disease, which it requires more than 7 days of recovery.
- •Major cardiovascular event (stroke, myocardial infarction) in the month prior to randomization.
- •Any other condition that the investigator considers to be inoperative so that the subject conducts the study.
研究组 & 干预措施
Sardine group
Experimental
干预措施: Sardine (Dietary Supplement)
Control group
Active Comparator
干预措施: Control (Dietary Supplement)
结局指标
主要结局
type 2 diabetes new onset
时间窗: Change from Baseline at 12 months
incidence of new diagnosis of type 2 diabetes
次要结局
- insulin levels(Change from Baseline at 12 months)
- adiponectin(Change from Baseline at 12 months)
- quantification of gut microbiota populations(Change from Baseline at 12 months)
- gene expression(Change from Baseline at 12 months)
- HOMA-IR (homeostasis model assessment insulin resistance)(Change from Baseline at 12 months)
- metabolomics study of dietary biomarkers and health biomarkers [(1) Fatty acyls, bile acids, steroids and lysoglycerophospholipids, (2) Glycerolipids, glycerophospholipids, sterol lipids and sphingolipids, (3) Amino acids.](Change from Baseline at 12 months)
- glucose homeostasis(Change from Baseline at 12 months)
- HOMA-B (homeostasis model assessment B cell function)(Change from Baseline at 12 months)
研究者
Diana Alicia Diaz Rizzolo
RD, Msc, PhD candidate
Institut d'Investigacions Biomèdiques August Pi i Sunyer
研究点 (2)
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