Effect of EPA-DHA Supplementation, Life Style Modification or Standard Treatment on Clinical Outcome and Lipid Membrane Composition in Type 2 Diabetic Patients: a 3 Months Perspective Randomized Pilot Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HbA1c < 7%
研究概览
简要总结
The aim of the present study is: to examine some of the mechanisms by which a change in life style alone or supplemented with a diet supplemented in n-3 PUFA, and associated with this computerized life style regulation reduces the development of diabetic complication in a small population based study.
(The NewMe™ / Eco-fusion, Ltd is a science-driven lifestyle change program for better living -www.eco-fusion.com)
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between 18-80 years of age.
- •Have been diagnosed with type 2 diabetes more than nine months before study entry, and, despite having been given standard dietary advice by dietitian, doctor, or nurse and prescribed oral hypoglycaemic agents, insulin, or both.
- •Have persistent unsatisfactory glycaemic control defined as HbA1c more than 7%.
- •Participants should have at least two of the following three characteristics:
- •Overweight or obesity (body mass index ≥25),
- •Hypertension (currently prescribed antihypertensive drugs or blood pressure >140/90 mm Hg despite optimized antihypertensive drug treatment),
- •Dyslipidaemia (currently prescribed lipid modifying drugs) or one or more of:
- •total cholesterol >5.2 mmol/l,
- •low density lipoprotein cholesterol >3.5 mmol/l,
- •triglycerides >2.0 mmol/l,
- •high density lipoprotein cholesterol <1.0 mmol/l (despite optimised lipid modifying drug treatment).
排除标准
- •Serious chronic illness.e.g cancer
- •End stage renal failure
- •Severe retinal microangiopathy
- •Pancreas transplantation
- •Requires diet only treatment
- •They are too busy with work
研究组 & 干预措施
A
Group A will continue their actual therapy (control).
B
Group B will continue their standard therapy with additional stress management application only using a mobile phone (Eco Fusion Mentally) for 3 months of the study
干预措施: Stress management phone application (Eco Fusion Mentally) (Behavioral)
B
Group B will continue their standard therapy with additional stress management application only using a mobile phone (Eco Fusion Mentally) for 3 months of the study
干预措施: mobile phone (Device)
C
Group C will continue their standard therapy with additional life style program using a mobile phone (Eco Mentally and NewMe) for 3 months of the study
干预措施: life style program using a mobile phone (Eco Mentally and NewMe) (Behavioral)
C
Group C will continue their standard therapy with additional life style program using a mobile phone (Eco Mentally and NewMe) for 3 months of the study
干预措施: mobile phone (Device)
D
Group D will continue their standard therapy plus additional life style program using a mobile phone with additional supplemental EPA and DHA capsules of 2 g/day to be taken daily for the 3 months of the study
干预措施: EPA and DHA capsules of 2 g/day (Dietary Supplement)
D
Group D will continue their standard therapy plus additional life style program using a mobile phone with additional supplemental EPA and DHA capsules of 2 g/day to be taken daily for the 3 months of the study
干预措施: life style program using a mobile phone (Eco Mentally and NewMe) (Behavioral)
D
Group D will continue their standard therapy plus additional life style program using a mobile phone with additional supplemental EPA and DHA capsules of 2 g/day to be taken daily for the 3 months of the study
干预措施: mobile phone (Device)
结局指标
主要结局
HbA1c < 7%
时间窗: 3 months
To attain individualized HbA1c \< 7% goal
次要结局
- Blood pressure< 140\80 mmHg(3 months)
- Lipid membrane fatty acid composition analysis(3 months)
- Changes in hypoglycaemic drugs (type and dose),(3 months)
- lipid profile. LDL cholesterol ,100 mg/dL; triglycerides ,150 mg/dL; HDL cholesterol .40 mg/dL for men; HDL cholesterol .50 mg/dL for women.(3 months)
- Fasting plasma glucose(3 months)
研究者
Pierre Singer
Professor
Rabin Medical Center