Clinical trial NCT03917940: Omega 3 Fatty Acids on Serum Irisin and Sirtuin-1 in Type 2 Diabetic Mellitus Patients Treated With Glimepiride
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Patients
Keywords: Irisin
sirtuin-1
Omega 3 fatty acids
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: serum Irisin concentration (ng/ml)
timeFrame: three months
measure: serum sirtuin-1 concentration (ng/ml)
timeFrame: three months
Secondary outcomes:
measure: Fasting Blood Sugar
timeFrame: Three Months
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Medical National Institute
state: El-Bahairah
Study officials:
affiliation: Pharmacology & Toxicology department- faculty of pharmacy- Damanhour University.
name: Maged W Helmy, Ass. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
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 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.