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

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ClinicalTrials.gov Identifier: NCT03917940
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Damanhour University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Patients Dietary Supplement: Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral Drug: Glimepiride Not Applicable

Detailed Description:
  1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University
  2. 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 3000 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Omega 3 + glimepiride
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
Omega 3 fatty acids 1000 mg per day oral
Other Name: Omega three

Placebo Comparator: Control
group 2: 35 patients treated with glimepiride 2mg or 3mg /day.
Drug: Glimepiride
glimepiride 2 mg or 3 mg per day oral
Other Name: Amaryl




Primary Outcome Measures :
  1. serum Irisin concentration (ng/ml) [ Time Frame: three months ]
    Myokines have anti- inflammatory properties

  2. serum sirtuin-1 concentration (ng/ml) [ Time Frame: three months ]
    class III protein deacetylase that is associated with aging, inflammation and CVD



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917940


Contacts
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Contact: Rehab H Werida, Lecturer 01005359968 Rehab_werida@hotmail.com
Contact: Alaa R Salem, Bachelor 01098748681 aalaaramzy2018@gmail.com

Locations
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Egypt
Damanhour Medical National Institute Recruiting
Damanhūr, El-Bahairah, Egypt, 31527
Contact: Youssri N Ebrahim., Prof    01098748681    dr.yousrynassief57@gmail.com   
Contact: Alaa Salem, Bachelor       aalaaramzy2018@gmail.com   
Sponsors and Collaborators
Damanhour University
Investigators
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Study Director: Maged W Helmy, Ass. Prof. Pharmacology & Toxicology department- faculty of pharmacy- Damanhour University.

Publications of Results:
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Responsible Party: Damanhour University
ClinicalTrials.gov Identifier: NCT03917940     History of Changes
Other Study ID Numbers: omega 3 in diabetics type 2
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Damanhour University:
Irisin
sirtuin-1
Omega 3 fatty acids

Additional relevant MeSH terms:
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Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors