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.
1 other identifier
interventional
60
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jun 2018
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedStudy Start
First participant enrolled
June 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedJanuary 9, 2019
January 1, 2019
8 months
March 6, 2016
January 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c < 7%
To attain individualized HbA1c \< 7% goal
3 months
Secondary Outcomes (5)
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
Study Arms (4)
A
NO INTERVENTIONGroup A will continue their actual therapy (control).
B
EXPERIMENTALGroup 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
EXPERIMENTALGroup 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
EXPERIMENTALGroup 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
Interventions
Stress management phone application (Eco Fusion Mentally)
life style program using a mobile phone (Eco Mentally and NewMe)
Eligibility Criteria
You may qualify if:
- 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:
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- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin medical center
Petah Tikva, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Singer, Professor
Head of General Intensive care unit
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 6, 2016
First Posted
March 10, 2016
Study Start
June 20, 2018
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
January 9, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share