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

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.

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)

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Singer, Professor; Phone Number: +972-3-9376521; Email: psinger@clalit.org.il

Study Locations

• Israel
  • Petah Tikva, Israel
    • Recruiting
    • Rabin Medical Center
    • Contact: Pierre Singer, Professor; Phone Number: 972544920184; Email: psinger@clalit.org.il
    • Contact: Sornwichate Rattanachaiwong, M.D.; Phone Number: 66817318004; Email: srattanamd@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:
   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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: A; Group A will continue their actual therapy (control).
Experimental: 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	Behavioral: Stress management phone application (Eco Fusion Mentally); Stress management phone application (Eco Fusion Mentally); Device: mobile phone; mobile phone
Experimental: 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	Device: mobile phone; mobile phone; Behavioral: life style program using a mobile phone (Eco Mentally and NewMe); life style program using a mobile phone (Eco Mentally and NewMe)
Experimental: 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	Device: mobile phone; mobile phone; Behavioral: life style program using a mobile phone (Eco Mentally and NewMe); life style program using a mobile phone (Eco Mentally and NewMe); Dietary supplement: EPA and DHA capsules of 2 g/day; EPA and DHA capsules of 2 g/day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Pierre Singer, Professor, Head of General Intensive care unit

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: March 6, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 0248-15-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No