Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change from baseline in major safety endpoints: Blood Pressure (BP)
研究概览
简要总结
This will be a double-blind, randomized, placebo-controlled, single dose study of (+)- epicatechin with one 30mg dose/day for a total of 7 days
详细描述
This project is a double-blinded, placebo-controlled, randomized, Phase I study that will include (+)-epicatechin dosing over seven days.
- Subjects will meet the American Diabetes Association (ADA) criteria for pre-diabetes, including impaired fasting glucose (IFG) [refer to inclusion/exclusion criteria].
- The Project includes: 7 day evaluation of a single daily dose of synthetic (+)-epicatechin in pre-diabetic individuals as compared to placebo.
- The Project has 4 outpatient clinic study visits: screening (Visit 1), randomization (Visit 2), end of study drug (Visit 3), follow up end of study (Visit 4).
- This Project has 2 telephone visits
Primary hypothesis: As these studies are designed to evaluate safety and tolerability, there is no primary hypothesis to test.
Primary outcome measures. Vital signs and safety labs: BP, HR, creatinine, alkaline phosphatase, and liver transaminases
These studies will provide initial data about if (+)-epicatechin can influence glycemic control in individuals with prediabetes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-diabetic based on medical history and screening results
- •Male or female
- •Must be 21 to 75 years of age (inclusive)
- •Able to give informed consent to the procedures
- •If female, must be either postmenopausal or test negative for pregnancy at screening and on the day of the procedure. Women on estrogen therapy will be included.
- •If female of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
- •Medication use stable for 4 weeks prior to screening
- •Body Mass Index (BMI) > 27 kg/m2
- •Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and/OR elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for diabetes
排除标准
- •Type 2 diabetes
- •Pregnancy
- •Younger than 21 or older than 75 years of age
- •Clinically significant abnormalities in liver or kidney function (>3x upper limit of normal (ULN)), determined in the last 6 months by a certified clinical laboratory
- •Recent myocardial infarct or stroke (within 6 months of screening)
- •Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic
- •Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs
- •Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism
研究组 & 干预措施
(+)-epicatechin 30mg
10 subjects will be randomized to a 30mg dose of synthetic (+)-epicatechin
干预措施: epicatechin (Drug)
placebo
5 subjects will be randomized to a placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in major safety endpoints: Blood Pressure (BP)
时间窗: Baseline and Day 7
Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change)
Change from baseline in major safety endpoints: Hepatic Function
时间窗: Baseline and Day 7
Clinically significant differences in the major safety endpoints are defined as: highly conservative changes in alkaline phosphatase and liver transaminases (\>1.5 ULN)
Change from baseline in major safety endpoints: Heart Rate (HR)
时间窗: Baseline and Day 7
Clinically significant differences in the major safety endpoints are defined as: HR (10 bpm)
Change from baseline in major safety endpoints: Kidney Function
时间窗: Baseline and Day 7
Clinically significant differences in the major safety endpoints are defined as: creatinine (\>1.5 ULN)
次要结局
- Change from baseline: Glucose(Baseline and Day 7)
- Change from baseline: C-Peptide(Baseline and Day 7)
- Change from baseline: Insulin(Baseline and Day 7)
研究者
Robert R. Henry, MD
Chief, Section of Diabetes, Endocrinology and Metabolism
Veterans Medical Research Foundation