Effect of EPA-DHA Supplement, Life Style Modification Standard Treatment on Clinical Outcome Lipid Membrane Composition in Type 2 Diabetes

Study Overview
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Brief Summary
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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)

Official Title
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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.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: EPA and DHA capsules of 2 g/day
* Behavioral: Stress management phone application (Eco Fusion Mentally)
* Behavioral: life style program using a mobile phone (Eco Mentally and NewMe)
* Device: mobile phone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Pregnancy Serious chronic illness.e.g cancer End stage renal failure Amputation Stroke Severe retinal microangiopathy Pancreas transplantation HbA1c <7% Requires diet only treatment They are too busy with work

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br>Group A will continue their actual therapy (control). | |
| Experimental: B<br>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 | Behavioral: Stress management phone application (Eco Fusion Mentally)<br>* Stress management phone application (Eco Fusion Mentally)<br>Device: mobile phone<br>* mobile phone<br>|
| Experimental: C<br>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 | Behavioral: life style program using a mobile phone (Eco Mentally and NewMe)<br>* life style program using a mobile phone (Eco Mentally and NewMe)<br>Device: mobile phone<br>* mobile phone<br>|
| Experimental: D<br>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 | Dietary Supplement: EPA and DHA capsules of 2 g/day<br>* EPA and DHA capsules of 2 g/day<br>Behavioral: life style program using a mobile phone (Eco Mentally and NewMe)<br>* life style program using a mobile phone (Eco Mentally and NewMe)<br>Device: mobile phone<br>* mobile phone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c < 7% | To attain individualized HbA1c < 7% goal | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hypoglycaemic drugs (type and dose), |  | 3 months | 
| Blood pressure< 140\80 mmHg |  | 3 months | 
| Fasting plasma glucose |  | 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 | 
| Lipid membrane fatty acid composition analysis |  | 3 months |