Omega 3 Fatty Acids on Serum Irisin and Sirtuin-1 in Type 2 Diabetic Mellitus Patients Treated With Glimepiride
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|ClinicalTrials.gov Identifier: NCT03917940|
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 18, 2019
|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||Not Applicable|
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University
- All Participants agreed to take part in this clinical study and provide informed consent.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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).|
|Masking:||None (Open Label)|
|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 :||January 1, 2019|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
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 Name: Omega three
Placebo Comparator: Control
group 2: 35 patients treated with glimepiride 2mg or 3mg /day.
glimepiride 2 mg or 3 mg per day oral
Other Name: Amaryl
- serum Irisin concentration (ng/ml) [ Time Frame: three months ]Myokines have anti- inflammatory properties
- serum sirtuin-1 concentration (ng/ml) [ Time Frame: three months ]class III protein deacetylase that is associated with aging, inflammation and CVD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917940
|Contact: Rehab H Werida, Lecturer||01005359968||Rehab_werida@hotmail.com|
|Contact: Alaa R Salem, Bacheloremail@example.com|
|Damanhour Medical National Institute||Recruiting|
|Damanhūr, El-Bahairah, Egypt, 31527|
|Contact: Youssri N Ebrahim., Prof 01098748681 firstname.lastname@example.org|
|Contact: Alaa Salem, Bachelor email@example.com|
|Study Director:||Maged W Helmy, Ass. Prof.||Pharmacology & Toxicology department- faculty of pharmacy- Damanhour University.|