Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in postprandial oxLDL
研究概览
简要总结
Is a randomized, double-blind, placebo-controlled trial to determine the behavior of hyperglycemia and postprandial lipemia after a standard mixed meal load in patients with carbohydrate intolerance treated with acarbose.
详细描述
To gather our patients, we invite the relatives of diabetic patients seen at the endocrinology consultation to participate in the study.
- Patients are placed into an isocaloric diet for 4 weeks before the study and are advised not to change their baseline physical activity.
- Patients are randomized to receive acarbose or placebo for 3 months blinded to investigators and patients.
- Acarbose dose is progressively titrated (50 mg/day per week up to 150 mg/day) to reduce the known adverse effects of acarbose such as flatulence, bloating, diarrhea, abdominal pain.
- In each subject, a 5-hr-postprandial mixed meal test is performed at baseline and after assigned treatment was completed. Glucose, insulin, triglycerides and total cholesterol were measured at 0, 5, 10, 20, 30, 60, 120, 180, 240 and 300 minutes after the mixed meal load. Apo B was measured by nephelometry and oxLDL using a monoclonal antibody 4E6 based competition (ELISA assay, Mercodia) at 0 and 300 minutes.
- The standard mixed meal load, a 470 kcal breakfast, (47.76% carbohydrate, 22.66% proteins, 29.58% fat), consisted of: 1 sandwich (prepared with 50 g of Savory´s™ turkey breast ham, 30 g of Savory´s™ panela cheese, 2 tablespoons of Hellmann's™ mayonnaise and 2 slices of Bimbo´s™ white bread), 100 g of Red DeliciousTM apple and 250 mL of Alpura´s™ lactose-free, light milk.
- During the 3-month treatment, patients have 3 follow-up monthly consultations to evaluate weight gain and treatment compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent diagnosis of carbohydrate intolerance according to the WHO criteria, without any treatment.
排除标准
- •patients with BMI >32 kg/m2, triglycerides and/or total cholesterol > 300 mg/dl, known renal, liver or gastrointestinal disease and positive smoking.
研究组 & 干预措施
Placebo
A placebo drug is given for three months
干预措施: Placebo (Drug)
Acarbose
Acarbose is given for three months
干预措施: Acarbose (Drug)
结局指标
主要结局
Change in postprandial oxLDL
时间窗: 3 months treatment
In each subject oxLDL is measured using a monoclonal antibody 4E6 based competition (ELISA assay, Mercodia) at 0 and 300 minutes in a postprandial 5 hour test, pre and post-treatment
次要结局
- Chance in postprandial hyperglycemia(3 months treatment)
- Chance in postprandial insulin levels(3 months treatment)
- Change in LDL concentration(3 months treatment)
- Change in HDL concentration(3 months treatment)
- Change in Apolipoprotein B (ApoB) concentration(3 months treatment)
研究者
Francisco J. Gómez Pérez
Chief of the Department of Endocrinology and Metabolism
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
