Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
Completed · Phase 1 · Has a placebo group
Conditions studied: Pre-diabetes
In brief
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
Key facts
- Study ID
- NCT02656212
- Run by
- Veterans Medical Research Foundation
- People needed
- 15
- Starts
- 2015-09-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-04-28
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CMR Center for Metabolic Research VASDHS — San Diego, California, United States
- VA San Diego Healthcare System — San Diego, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.