Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

Completed · Phase 1 · Has a placebo group

Conditions studied: Pre-diabetes

In brief

Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.

Key facts

Study ID: NCT02330276
Run by: Veterans Medical Research Foundation
People needed: 12
Starts: 2014-09-01
Expected to finish: 2015-08-01
Last updated by the study team: 2017-04-17

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy or pre-diabetic based on medical history
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 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
Body Mass Index (BMI) > 27 kg/m\^2
Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and 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 ULN), determined in the last 6 months by a certified clinical laboratory
Recent MI 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

VA San Diego Healthcare System — San Diego, California, United States

Full record on ClinicalTrials.gov

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