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

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: life style program using a mobile phone (Eco Mentally and NewMe); Dietary Supplement: EPA and DHA capsules of 2 g/day; Behavioral: Stress management phone application (Eco Fusion Mentally); Device: mobile phone

• Registration Number: NCT02705430
• Lead Sponsor: Rabin Medical Center

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-10
• Study Start: 2018-06-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Participants between 18-80 years of age.

2. 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.

3. Have persistent unsatisfactory glycaemic control defined as HbA1c more than 7%.

4. Participants should have at least two of the following three characteristics:

   1. Overweight or obesity (body mass index ≥25),
   2. Hypertension (currently prescribed antihypertensive drugs or blood pressure >140/90 mm Hg despite optimized antihypertensive drug treatment),
   3. Dyslipidaemia (currently prescribed lipid modifying drugs) or one or more of:
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   1. total cholesterol >5.2 mmol/l,
   2. low density lipoprotein cholesterol >3.5 mmol/l,
   3. triglycerides >2.0 mmol/l,
   4. high density lipoprotein cholesterol <1.0 mmol/l (despite optimised lipid modifying drug treatment).

Exclusion Criteria

1. Pregnancy
2. Serious chronic illness.e.g cancer
3. End stage renal failure
4. Amputation
5. Stroke
6. Severe retinal microangiopathy
7. Pancreas transplantation
8. HbA1c <7%
9. Requires diet only treatment
10. They are too busy with work

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	life style program using a mobile phone (Eco Mentally and NewMe)	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
B	mobile phone	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
C	mobile phone	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
D	EPA and DHA capsules of 2 g/day	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
B	Stress management phone application (Eco Fusion Mentally)	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
D	life style program using a mobile phone (Eco Mentally and NewMe)	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
D	mobile phone	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

Primary Outcome Measures

Name	Time	Method
HbA1c < 7%	3 months	To attain individualized HbA1c \< 7% goal

Secondary Outcome Measures

Name	Time	Method
Blood pressure< 140\80 mmHg	3 months
Lipid membrane fatty acid composition analysis	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
Changes in hypoglycaemic drugs (type and dose),	3 months

Trial Locations

Locations (1)

Rabin medical center; 🇮🇱 Petah Tikva, Israel