Diabetes Mellitus Type II
Conditions
Keywords
EPA, Paraoxonase 1, Paraoxonase 2, Type 2 diabetes
Brief summary
The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum levels of some indicators of vascular inflammation, and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus.
Detailed description
The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase and several indicators of vascular inflammation and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus. In this randomized, double-blind clinical trial, placebo-controlled, single-center, 36 men and women aged 35-50 years with type 2 diabetes are enrolled in the study from the Iranian Diabetes Association. After signing informed consent, all individuals complete a general information form. a 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. Two groups will be classified (blocked) based on sex. The supplement group, will receive 2 g/day EPA for 8 weeks and the placebo group will also receive placebo (containing 2 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropocentric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured.
Interventions
DIETARY_SUPPLEMENTEPA Supplement
EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.
DIETARY_SUPPLEMENTEPA Placebo
EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Willingness to collaborate in the study * aged 35-50 years * having a history of at least 1 year of type 2 diabetes mellitus before the participation in the study based on FBS ≥126 mg/dl or 2hPG ≥200 mg/dl (2-hour plasma glucose), * 25≤BMI\<30 kg/m2
Exclusion criteria
* pregnant and breastfeeding women * using insulin, alcohol consumption, smoking and other drugs * taking drugs (lipid-lowering, β-blockers, diuretics, estrogens, progesterones, vitamin supplements and ω-3 fatty acid supplements * followers of the special diet * history of diabetic retinopathy or diabetic nephropathy * type 1 diabetes mellitus and other disorders * any need to take insulin, change in the dose (s) and type of medication or physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Change from Baseline at 8 weeks after the intervention | Hemoglobin A1c (HbA1c) measurement by related kits according their protocols |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PON2 gene expression | Baseline, 8 weeks after the intervention | measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR |
| Systolic blood pressure | Change frome baseline at 8 weeks | Systolic blood pressure changes measurement by manometer |
| Diastolic blood pressure | Change frome baseline at 8 weeks | Diastolic blood pressure changes measurement by manometer |
| serum paraoxonase-1(PON-1) activity | Baseline, 8 weeks after the intervention | serum paraoxonase-1(PON-1) activity by kit according related protocol |
| PON1/HDL-c Ratio | Baseline, 8 weeks after the intervention | calculating the ratio after measurement of PON1 and HDL-c by related kits according their protocols |
| serum paraoxonase lactonase (PON-HCTLase) activity | Baseline, 8 weeks after the intervention | measurement of paraoxonase lactonase (PON-HCTLase) activity by related kit according its protocol |
| HDL-c | Baseline, 8 weeks after the intervention | high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols |
| FBS | Baseline, 8 weeks after the intervention | Fasting blood sugar (FBS) measurement by related kits according their protocols |
| HDL2-c | Baseline, 8 weeks after the intervention | high density lipoprotein 2- cholesterol (HDL2-c) measurement by related kits according their protocols |
| HDL3-c | Baseline, 8 weeks after the intervention | high density lipoprotein 3- cholesterol (HDL3-c) measurement by related kits according their protocols |
| Serum apo A-I | Baseline, 8 weeks after the intervention | Serum apo-protein A-I measurement by related kits according their protocols |
| apo B/apo A-I Ratio | Baseline, 8 weeks after the intervention | calculating the ratio after measurement of apo B and apo A-1 by related kits according their protocols |
| Serum methionine | Baseline, 8 weeks after the intervention | measurement of serum levels of methionine by related kit according its protocol |
| Serum malondialdehyde (MDA) | Baseline, 8 weeks after the intervention | measurement of serum levels of malondialdehyde (MDA)by related kit according its protocol |
| Serum homocysteine (Hcy) | Baseline, 8 weeks after the intervention | measurement of serum levels of homocysteine (Hcy) by related kit according its protocol |
| Serum sE-Selectin | Baseline, 8 weeks after the intervention | measurement of serum levels of soluble E-Selectin by related kit according its protocol |
| sVCAM-1 | Baseline, 8 weeks after the intervention | measurement of serum levels of soluble Vascular cell adhesion molecule-1 (VCAM-1) by related kit according its protocol |
| Serum cysteine | Baseline, 8 weeks after the intervention | measurement of serum levels of cysteine by related kit according its protocol |
| Serum Lpa | Baseline, 8 weeks after the intervention | measurement of serum levels of lipoprotein-a (Lpa)by related kit according its protocol |
| Serum apo B | Baseline, 8 weeks after the intervention | Serum apo-protein B measurement by related kits according their protocols |
Countries
Iran
Outcome results
None listed