Diabetic Patients
Conditions
Keywords
Irisin, sirtuin-1, Omega 3 fatty acids
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.
Interventions
DIETARY_SUPPLEMENTOmega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral
Omega 3 fatty acids 1000 mg per day oral
DRUGGlimepiride
glimepiride 2 mg or 3 mg per day oral
Sponsors
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Single Blind
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).
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum Irisin concentration (ng/ml) | three months | Myokines have anti- inflammatory properties |
| serum sirtuin-1 concentration (ng/ml) | three months | class III protein deacetylase that is associated with aging, inflammation and CVD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Sugar | Three Months | Serum Glucose (mg/dl) |
Countries
Egypt
Outcome results
None listed