Omega 3 Fatty Acids on Serum Irisin and Sirtuin-1 in Type 2 Diabetic Mellitus Patients Treated With Glimepiride

Study Overview
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Brief Summary
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study the effect of omega 3 fatty acids on blood glucose, lipids profile, serum Irisin and sirtuin-1 in type 2 diabetic mellitus patients treated with glimepiride.

Detailed Description
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Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University All Participants agreed to take part in this clinical study and provide informed consent. Methodology The study will be conducted in 70 patients who are aged 30-60 years old with type 2 diabetes mellitus for at least 2 years. The patients will be assigned into two groups (Omega - 3/glimepiride, n=35; glimepiride, n=35). Serum Irisin, sirtuin-1, Hb A1C, Fasting blood sugar (FBS), Lipid profile, Fasting insulin, HOMA-IR and Atherogenic index of plasma (AIP) will be measured at the beginning and after 12 weeks of intervention. Anthro-pometric parameters including Weight and height to calculate body mass index will be measured at the beginning and after intervention. past medical history and medication history will be documented. Each subject in the test group will receive a total dose of 1000 mg of omega-3 fatty acids per day in the form of three capsules along with a glimepiride tablet to be taken once daily, while each subject in the other group will receive glimepiride tablet to be taken once daily for 12 weeks. Venous blood samples will be obtained from patients at the beginning and after 12 weeks of intervention. A commercially available enzyme-linked immuno-sorbent assay kits will be used for the measurement of Irisin and sirtuin-1. The patients will be advised not to change their usual diet, drug regimen and physical activity levels throughout the study.

Official Title
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The Effect of Omega 3 Fatty Acids on Blood Glucose, Lipids Profile, Serum Irisin and Sirtuin-1 in Type 2 Diabetic Mellitus Patients Treated With Glimepiride

Conditions
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Diabetic Patients

Intervention / Treatment
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* Dietary Supplement: Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral
* Drug: Glimepiride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 70 Adult patients aged 30-60 years old with type 2 diabetes mellitus treated with glimepiride. glycated hemoglobin percent greater than 7%. body mass index between 25 and 35 kg/m2. Patients who are not consuming omega-3 fatty acids, supplements or any pharmaceutical products that may interact with their lipid profile. Exclusion Criteria: Pregnant or lactating women. Have gastrointestinal disorders that interfere with the bowel function patients with severe hepatic, renal, inflammatory and thyroid diseases. insulin therapy. Have diabetes complications including micro and macrovascular complications. Alcoholics and patients with past history of drug abuse.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be divided into two groups: group 1 treated with (Omega - 3 and glimepiride, n=35). group 2 treated with glimepiride alone, n=35).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega 3 + glimepiride<br>group 1: 35 patients treated with (Omega - 3 1000mg / day oral plus glimepiride 2mg or 3mg /day. | Dietary Supplement: Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral<br>* Omega 3 fatty acids 1000 mg per day oral<br>* Other names: Omega three;|
| Placebo Comparator: Control<br>group 2: 35 patients treated with glimepiride 2mg or 3mg /day. | Drug: Glimepiride<br>* glimepiride 2 mg or 3 mg per day oral<br>* Other names: Amaryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum Irisin concentration (ng/ml) | Myokines have anti- inflammatory properties | three months | 
| serum sirtuin-1 concentration (ng/ml) | class III protein deacetylase that is associated with aging, inflammation and CVD | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Blood Sugar | Serum Glucose (mg/dl) | Three Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irisin, sirtuin-1, Omega 3 fatty acids