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

November 18, 2023 updated by: Rehab Werida, Damanhour University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Bahairah
      • Damanhūr, El-Bahairah, Egypt, 31527
        • Damanhour Medical National Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Amaryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum Irisin concentration (ng/ml)
Time Frame: three months
Myokines have anti- inflammatory properties
three months
serum sirtuin-1 concentration (ng/ml)
Time Frame: three months
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
Time Frame: Three Months
Serum Glucose (mg/dl)
Three Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Study Director: Maged W Helmy, Ass. Prof., Pharmacology & Toxicology department- faculty of pharmacy- Damanhour University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2019

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 10, 2020

Study Registration Dates

First Submitted

April 14, 2019

First Submitted That Met QC Criteria

April 16, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 18, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • omega 3 in diabetics type 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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