Omega 3 Fatty Acids on Serum Irisin and Sirtuin-1 in Type 2 Diabetic Mellitus Patients Treated With Glimepiride
NCT ID: NCT03917940
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2019-01-31
2020-05-10
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Omega 3 + glimepiride
group 1: 35 patients treated with (Omega - 3 1000mg / day oral plus glimepiride 2mg or 3mg /day.
Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral
Omega 3 fatty acids 1000 mg per day oral
Control
group 2: 35 patients treated with glimepiride 2mg or 3mg /day.
Glimepiride
glimepiride 2 mg or 3 mg per day oral
Interventions
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Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral
Omega 3 fatty acids 1000 mg per day oral
Glimepiride
glimepiride 2 mg or 3 mg per day oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
60 Years
ALL
No
Sponsors
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Damanhour University
OTHER
Responsible Party
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Rehab Werida
Clinical Pharmacy Lecturer
Principal Investigators
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Maged W Helmy, Ass. Prof.
Role: STUDY_DIRECTOR
Pharmacology & Toxicology department- faculty of pharmacy- Damanhour University.
Locations
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Damanhour Medical National Institute
Damanhūr, El-Bahairah, Egypt
Countries
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References
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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 in type 2 diabetic patients: a study protocol for a randomized placebo-controlled clinical trial. BMC Complement Altern Med. 2018 Jan 17;18(1):18. doi: 10.1186/s12906-017-2068-6.
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 acid/Docosahexaenoic acid 1:1 ratio on cardiovascular disease risk markers in rats. Lipids Health Dis. 2013 Oct 1;12:140. doi: 10.1186/1476-511X-12-140.
Werida RH, Ramzy A, Ebrahim YN, Helmy MW. Effect of coadministration of omega-3 fatty acids with glimepiride on glycemic control, lipid profile, irisin, and sirtuin-1 in type 2 diabetes mellitus patients: a randomized controlled trial. BMC Endocr Disord. 2023 Nov 25;23(1):259. doi: 10.1186/s12902-023-01511-2.
Other Identifiers
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omega 3 in diabetics type 2
Identifier Type: -
Identifier Source: org_study_id