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

• Sponsor: Damanhour University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03917940
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.3
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual 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).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: Single (Participant)
• Masking Description: Single Blind
• 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: Jan 31, 2019
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: May 10, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. serum Irisin concentration (ng/ml) [three months]

   Myokines have anti- inflammatory properties

2. serum sirtuin-1 concentration (ng/ml) [three months]

   class III protein deacetylase that is associated with aging, inflammation and CVD

Secondary Outcome Measures

1. Fasting Blood Sugar [Three Months]

   Serum Glucose (mg/dl)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damanhour Medical National Institute	Damanhūr	El-Bahairah	Egypt	31527

Sponsors and Collaborators

• Damanhour University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rehab Werida, Clinical Pharmacy Lecturer, Damanhour University
• ClinicalTrials.gov Identifier: NCT03917940
• Other Study ID Numbers: omega 3 in diabetics type 2
• First Posted: Apr 17, 2019
• Last Update Posted: Feb 9, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rehab Werida, Clinical Pharmacy Lecturer, Damanhour University: Irisin; sirtuin-1; Omega 3 fatty acids
• Additional relevant MeSH terms: Glimepiride

Study Results

No Results Posted as of Feb 9, 2021