Double-blind and Placebo-controlled Study on Intervention Effect of n-3 Fatty Acids on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 415
- 试验地点
- 1
- 主要终点
- Change in blood glucose from baseline
研究概览
简要总结
A double-blind and placebo-controlled study is conducted in the current human study.
The purpose of this study is to investigate the effects of n-3 PUFA intervention on glucose and lipid homeostasis in Chinese diabetic/obese patients.
详细描述
Approximately 450 diabetic and 450 obese patients will be enrolled from Lanxi in China. They will be randomly assigned into one of the following three groups: Omega-3 fatty acids capsules (1.5 g/d); or omega-3 fatty acids capsules (3 g/d); or placebo capsules. Blood, feces and urine samples will be collected before and after treatment. Glucose and lipid parameters will be measured. Diabetes comorbidities and complications will also be assessed. This study will also explore the new mechanisms of n-3 PUFAs on improving glucose and lipid homeostasis and other outcomes based on multi-omics and establish a model for precision intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed type 2 diabetes for diabetic groups according to WHO diagnostic criteria;
- •BMI≥28 for obese groups;
- •Aged between 40 and 75 years.
排除标准
- •Type 1 diabetes;
- •Cardiovascular disease;
- •Liver or kidney disease;
- •Premenopausal women, pregnancy or lactation;
- •Allergy to fish;
- •Have participated in other clinical trials in the last three months.
研究组 & 干预措施
Low dose group
Low-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 1.5 grams per day for 1 year.
干预措施: Low dose omega-3 fatty acid supplementation (Drug)
High dose group
High-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 3 grams per day for 1 year.
干预措施: High dose omega-3 fatty acid supplementation (Drug)
Control group
Control drug, matching placebo capsules, 3 grams per day for 1 year.
干预措施: Control drug (Drug)
结局指标
主要结局
Change in blood glucose from baseline
时间窗: 12 months
The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.
Change in blood lipids from baseline
时间窗: 12 months
The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
Change in carotid plaque and carotid intima-meida thickness
时间窗: 12 months
A FUJIFILM SonoSite ultrasound system will be used to assess carotid artery plaque lesions and measure carotid intima-media thickness (CIMT).
次要结局
- Change in gut microbiota from baseline(12 months)
- Change in sleep quality(12 months)
- Change in cognitive function(12 months)
- Change in bone mineral density (BMD)(12 months)
- Change in body fat distribution(12 months)
- Change in urinary protein concentration(12 months)
- Change in estimated glomerular filtration rate (eGFR)(12 months)
- Change in blood metabolome(12 months)
研究者
Jingjing Jiao
Associate Professor
Zhejiang University