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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- serum Irisin concentration (ng/ml)
研究概览
简要总结
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.
详细描述
- 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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Single Blind
入排标准
- 年龄范围
- 30 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •Patients who are not consuming omega-3 fatty acids, supplements or any pharmaceutical products that may interact with their lipid profile.
排除标准
- •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.
研究组 & 干预措施
Omega 3 + glimepiride
group 1: 35 patients treated with (Omega - 3 1000mg / day oral plus glimepiride 2mg or 3mg /day.
干预措施: Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral (Dietary Supplement)
Control
group 2: 35 patients treated with glimepiride 2mg or 3mg /day.
干预措施: Glimepiride (Drug)
结局指标
主要结局
serum Irisin concentration (ng/ml)
时间窗: three months
Myokines have anti- inflammatory properties
serum sirtuin-1 concentration (ng/ml)
时间窗: three months
class III protein deacetylase that is associated with aging, inflammation and CVD
次要结局
- Fasting Blood Sugar(Three Months)
研究者
Rehab Werida
Clinical Pharmacy Lecturer
Damanhour University
