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

Clalit Health Services

Status: Unknown

Conditions: Type 2 Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02705430

0248-15-RMC

Details and patient eligibility

About

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)

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

A

No Intervention group

Description:

Group A will continue their actual therapy (control).

B

Experimental group

Description:

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

Treatment:

Behavioral: Stress management phone application (Eco Fusion Mentally)

Device: mobile phone

C

Experimental group

Description:

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

Treatment:

Behavioral: life style program using a mobile phone (Eco Mentally and NewMe)

Device: mobile phone

D

Experimental group

Description:

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

Treatment:

Dietary Supplement: EPA and DHA capsules of 2 g/day

Behavioral: life style program using a mobile phone (Eco Mentally and NewMe)

Device: mobile phone