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

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ClinicalTrials.gov Identifier: NCT02705430
Recruitment Status : Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Pierre Singer, 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)


Condition or disease Intervention/treatment Phase
Type 2 Diabetes 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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

Device: mobile phone
mobile phone

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

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

Device: mobile phone
mobile phone




Primary Outcome Measures :
  1. HbA1c < 7% [ Time Frame: 3 months ]
    To attain individualized HbA1c < 7% goal


Secondary Outcome Measures :
  1. Changes in hypoglycaemic drugs (type and dose), [ Time Frame: 3 months ]
  2. Blood pressure< 140\80 mmHg [ Time Frame: 3 months ]
  3. Fasting plasma glucose [ Time Frame: 3 months ]
  4. 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 ]
  5. Lipid membrane fatty acid composition analysis [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705430


Contacts
Contact: Pierre Singer, Professor +972-3-9376521 psinger@clalit.org.il

Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Pierre Singer, Professor Head of General Intensive care unit

Responsible Party: Pierre Singer, Professor, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02705430     History of Changes
Other Study ID Numbers: 0248-15-RMC
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases