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NCT Number: NCT03917940

Omega 3 Fatty Acids on 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.

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Key information

Conditions

Diabetic Patients

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour Medical National Institute

Damanhūr, El-Bahairah, 31527, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral

Dietary Supplement

Omega 3 fatty acids 1000 mg per day oral

Other names: Omega three

Glimepiride

Drug

glimepiride 2 mg or 3 mg per day oral

Other names: Amaryl

Primary outcomes

  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

Secondary outcomes

  1. Fasting Blood Sugar

    Time frame: Three Months

    Serum Glucose (mg/dl)

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2019
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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