Effect of the Administration of Chlorogenic Acid on Glucemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fasting Plasma Glucose (FPG)
研究概览
简要总结
Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control, obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show that Chlorogenic acid has an excellent potential for the control of glucose as well as insulin secretion and insulin sensitivity.
详细描述
A randomized, double-blind, placebo-controlled clinical trial was carried out in 30 patients with a diagnosis of impaired glucose tolerance in accordance with the American Diabetes Association criteria. The patients received 400 mg capsules of Chlorogenic acid or placebo, three times daily 1/ 2 hour before meals for 90 days. Before and after intervention the investigators evaluated: 2 hours plasma glucose, glycated hemoglobin (A1C), triglycerides, high-density lipoprotein, fasting glucose and blood pressure body weight, body mass index, waist circumference, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.
Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI: 30.0-34.99 kg / m
- •Diagnosis of IGT (OGTT Values between 140mg / dl and 199mg / dl.
- •Written informed consent.
- •Body weight stable over the last 3 months.
- •Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.
- •Women who are not contemplated get pregnant within the next 6 months.
排除标准
- •Women pregnant or breastfeeding.
- •Physical or mental disability that makes it impossible to perform the intervention.
- •Diagnosis of Hypertension or heart failure.
- •Untreated thyroid disease.
- •Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).
- •Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.
- •Diagnosis of renal disease or creatinine > 1.5 mg / dl.
- •Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.
- •Total Cholesterol ≥ 280 mg/dL.
- •Triglycerids ≥ 300 mg/dL.
- •Known allergy to calcined magnesia or Chorogenic acid.
研究组 & 干预措施
Placebo
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
干预措施: Placebo (Drug)
Chlorogenic acid
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
干预措施: Chlorogenic acid (Drug)
结局指标
主要结局
Fasting Plasma Glucose (FPG)
时间窗: Week 12.
Reflect the fasting glucose level after a 10- to 12-h overnight fast.
2 Hours Plasma Glucose (2-h PG)
时间窗: Week 12.
Subjects underwent a 2-h oral glucose tolerance test (2-h OGTT) by consuming 75-g of a dextrose load, and one sample was obtained 120 min after glucose administration.
Glycated Hemoglobin A1c (A1C)
时间窗: Week 12.
Shows what a person's average blood glucose level was for the 2 to 3 months before the test high-performance.
Total Insulin Secretion
时间窗: Week 12.
After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).
First Phase of Insulin Secretion
时间窗: Week 12.
After intervention with Stumvoll index
Insulin Sensitivity
时间窗: Week 12.
After intervention Matsuda Index
次要结局
- Area Under the Curve of Glucose(Week 12.)
- Area Under the Curve of Insulin(Week 12.)
- Body Weight(Week 12.)
- Body Mass Index(Week 12.)
- Waist Circumference (WC)(Week 12.)
- Systolic Blood Pressure (SBP)(Week 12.)
- Triglycerides (TG)(Week 12.)
- Total Cholesterol (TC)(Week 12.)
- High-density Lipoprotein Cholesterol (HDL-C)(Week 12.)
- Diastolic Blood Plessure (DBP)(Week 12.)
- Low-density Lipoprotein Cholesterol (LDL-C)(Week 12.)
- Very-low Density Lipoprotein (VLDL)(Week 12.)
- Glutamic Pyruvic Transaminase (GPT)(Week 12.)
- Glutamic Oxaloacetic Transaminase (GOT)(Week 12.)
- Creatinine(Week 12.)
- Uric Acid(Week 12.)
研究者
Esperanza Martínez-Abundis
Researcher Professor
University of Guadalajara