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临床试验/NCT03917940
NCT03917940已完成不适用

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

Damanhour University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年1月31日最近更新:
适应症
干预措施
相关药物

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

  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.

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

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

Experimental

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

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rehab Werida

Clinical Pharmacy Lecturer

Damanhour University

研究点 (1)

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