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

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02705430
• Other study ID #: 0248-15-RMC
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: March 2019

Study information

• Verified date: January 2019
• Source: Rabin Medical Center
• Contact: Pierre Singer, Professor
• Phone: +972-3-9376521
• Email: psinger[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Behavioral:
• Stress management phone application (Eco Fusion Mentally)
Stress management phone application (Eco Fusion Mentally)
• 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

Locations

Country	Name	City	State
Israel	Rabin medical center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c < 7%	To attain individualized HbA1c < 7% goal	3 months
Secondary	Changes in hypoglycaemic drugs (type and dose),		3 months
Secondary	Blood pressure< 140\80 mmHg		3 months
Secondary	Fasting plasma glucose		3 months
Secondary	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
Secondary	Lipid membrane fatty acid composition analysis		3 months