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

Primary Purpose

Type 2 Diabetes

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

EPA and DHA capsules of 2 g/day

Stress management phone application (Eco Fusion Mentally)

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

mobile phone

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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:

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

Sites / Locations

Rabin medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

Group A will continue their actual therapy (control).

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

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

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

Outcomes

Primary Outcome Measures

HbA1c < 7%

To attain individualized HbA1c < 7% goal

Secondary Outcome Measures

Changes in hypoglycaemic drugs (type and dose),

Blood pressure< 140\80 mmHg

Fasting plasma glucose

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.

Lipid membrane fatty acid composition analysis

Full Information

NCT ID

NCT02705430

First Posted

March 6, 2016

Last Updated

January 8, 2019

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02705430

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 20, 2018 (Actual)

Primary Completion Date

March 2019 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rabin Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Group A will continue their actual therapy (control).

Arm Title

Arm Type

Experimental

Arm 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

Arm Title

Arm Type

Experimental

Arm 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

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

EPA and DHA capsules of 2 g/day

Intervention Description

EPA and DHA capsules of 2 g/day

Intervention Type

Behavioral

Intervention Name(s)

Stress management phone application (Eco Fusion Mentally)

Intervention Description

Stress management phone application (Eco Fusion Mentally)

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

mobile phone

Intervention Description

mobile phone

Primary Outcome Measure Information:

Title

HbA1c < 7%

Description

To attain individualized HbA1c < 7% goal

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Changes in hypoglycaemic drugs (type and dose),

Time Frame

3 months

Title

Blood pressure< 140\80 mmHg

Time Frame

3 months

Title

Fasting plasma glucose

Time Frame

3 months

Title

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.

Time Frame

3 months

Title

Lipid membrane fatty acid composition analysis

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre Singer, Professor

Phone

+972-3-9376521

psinger@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre Singer, Professor

Organizational Affiliation

Head of General Intensive care unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rabin medical center

City

Petah Tikva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre Singer, Professor

Phone

972544920184

psinger@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Sornwichate Rattanachaiwong, M.D.

Phone

66817318004

srattanamd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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