NCT03917940

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetic Patients

Interventions

Type	Name	Description
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
DRUG	Glimepiride	glimepiride 2 mg or 3 mg per day oral

Timeline

• Start date: 2019-01-31
• Primary completion: 2020-05-01
• Completion: 2020-05-10
• First posted: 2019-04-17
• Last updated: 2023-11-22

Locations

1 site across 1 country: Egypt