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

Diabetic Patients Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917940
• Other study ID #: omega 3 in diabetics type 2
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: May 10, 2020

Study information

• Verified date: November 2023
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 10, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Patients

Intervention

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

Locations

Country	Name	City	State
Egypt	Damanhour Medical National Institute	Damanhur	El-Bahairah

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Aghasi M, Ghazi-Zahedi S, Koohdani F, Siassi F, Nasli-Esfahani E, Keshavarz A, Qorbani M, Khoshamal H, Salari-Moghaddam A, Sotoudeh G. The effects of green cardamom supplementation on blood glucose, lipids profile, oxidative stress, sirtuin-1 and irisin i — View Citation

Lluis L, Taltavull N, Munoz-Cortes M, Sanchez-Martos V, Romeu M, Giralt M, Molinar-Toribio E, Torres JL, Perez-Jimenez J, Pazos M, Mendez L, Gallardo JM, Medina I, Nogues MR. Protective effect of the omega-3 polyunsaturated fatty acids: Eicosapentaenoic a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum Irisin concentration (ng/ml)	Myokines have anti- inflammatory properties	three months
Primary	serum sirtuin-1 concentration (ng/ml)	class III protein deacetylase that is associated with aging, inflammation and CVD	three months
Secondary	Fasting Blood Sugar	Serum Glucose (mg/dl)	Three Months