Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Diabet
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- rate of continuous glycemic monitoring and Hemoglobin A1C
研究概览
简要总结
This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).
Patients over 18 years of age with:
-Diabets
详细描述
This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).
All the population will benifit of a biological assessment which include:
- Complete lipid profile, blood sugar, creatinine
- HbA1c (if the patient is diabetic).
- Inflammatory assessment: reactive protein C One population will be rendomized:The population with diabetes. In each study population, the patient will be assigned to one of two treatments (atherolive or placebo). The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.
Continuous blood glucose monitoring to measure indices of glycemic variability is performed at baseline. These patients will be equipped with an iPro continuous glycemic monitoring
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Active Comparator: atherolive group Placebo Comparator: placebo group
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age with:
- •diabetes.
排除标准
- •Exclusion criteria: None.
研究组 & 干预措施
atherolive
In this Arm the patient will receive the study drug (atherol) that will be prescribed at a dose of 400 mg, once a day for 3 months.
干预措施: Atherolive (Drug)
placebo atherolive
In this Arm patients will receive the placebo at a dose of 400 mg once a day for 3 months.
干预措施: Placebo Atherolive (Drug)
结局指标
主要结局
rate of continuous glycemic monitoring and Hemoglobin A1C
时间窗: 90 days
Patients will be fitted with an iPro continuous glycemic monitoring (CGM) recorder (Medtronic, Northridge, CA) for 24 consecutive hours on an outpatient basis . A CGM (Enlite Sensor) sensor is inserted into abdominal (or arm) fatty tissue subcutaneously and calibrated according to Medtronic standard operating guidelines. The iPro Continuous Glucose Recorder measures interstitial subcutaneous tissue glucose levels continuously, recording values every 5 minutes, over a range of 40-400 mg/dL.recorded data will be downloaded for analysis of glucose profile and glucose excursion parameters with the CareLink iPro system. Analysis will be performed on the data obtained within the 24-hour period after placement.
次要结局
- variation in lipid balance(90 days)
- rate of hospitalization for cardiovascular disease and adverse effects(90 days)
研究者
Pr. Semir Nouira
clinical proffesor
University of Monastir