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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 NewMeâ„¢ / Eco-fusion, Ltd is a science-driven lifestyle change program for better living -www.eco-fusion.com)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | No Intervention | Group A will continue their actual therapy (control). | |
| B | Experimental | 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 |
|
| C | Experimental | 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 |
|
| D | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA and DHA capsules of 2 g/day | Dietary Supplement | EPA and DHA capsules of 2 g/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c < 7% | To attain individualized HbA1c < 7% goal | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hypoglycaemic drugs (type and dose), | 3 months | |
| Blood pressure< 140\80 mmHg | 3 months | |
| Fasting plasma glucose |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Singer, Professor | Contact | +972-3-9376521 | psinger@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Singer, Professor | Head of General Intensive care unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin medical center | Recruiting | Petah Tikva | Israel |
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| Stress management phone application (Eco Fusion Mentally) |
| Behavioral |
Stress management phone application (Eco Fusion Mentally) |
|
| life style program using a mobile phone (Eco Mentally and NewMe) | Behavioral | life style program using a mobile phone (Eco Mentally and NewMe) |
|
| mobile phone | Device | mobile phone |
|
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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