Clinical trial NCT02705430: Effect of EPA-DHA Supplement, Life Style Modification Standard Treatment on Clinical Outcome Lipid Membrane Composition in Type 2 Diabetes
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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Eligibility 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:

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   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

Primary outcomes:
measure: HbA1c < 7%
timeFrame: 3 months
Secondary outcomes:
measure: Changes in hypoglycaemic drugs (type and dose),
timeFrame: 3 months
measure: Blood pressure< 140\80 mmHg
timeFrame: 3 months
measure: Fasting plasma glucose
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
measure: Lipid membrane fatty acid composition analysis
timeFrame: 3 months
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin medical center
Study officials:
affiliation: Head of General Intensive care unit
name: Pierre Singer, Professor
role: PRINCIPAL_INVESTIGATOR
References: