Type 2 Diabetes
Conditions
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)
Interventions
DIETARY_SUPPLEMENTEPA and DHA capsules of 2 g/day
EPA and DHA capsules of 2 g/day
BEHAVIORALStress management phone application (Eco Fusion Mentally)
Stress management phone application (Eco Fusion Mentally)
BEHAVIORALlife style program using a mobile phone (Eco Mentally and NewMe)
life style program using a mobile phone (Eco Mentally and NewMe)
DEVICEmobile phone
mobile phone
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c < 7% | 3 months | To attain individualized HbA1c \< 7% goal |
Secondary
| 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 |
Countries
Israel
Contacts
Primary ContactPierre Singer, Professor
Outcome results
None listed