Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)

Pre-diabetes Clinical Trial

— Epicatechin  

Official title:

Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656212
• Other study ID #: 08847002
• Secondary ID: 1R01AT008310-01
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2016
• Last updated: April 26, 2016
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Drug:
• epicatechin
30 mg (+)-epicatechin, taken orally, one pill/day in the morning
• Placebo
Placebo pill, taken orally, one pill/day in the morning

Locations

Country	Name	City	State
United States	CMR Center for Metabolic Research VASDHS	San Diego	California
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH), San Diego Veterans Healthcare System, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in major safety endpoints: Blood Pressure (BP)	Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change)	Baseline and Day 7	Yes
Primary	Change from baseline in major safety endpoints: Heart Rate (HR)	Clinically significant differences in the major safety endpoints are defined as: HR (10 bpm)	Baseline and Day 7	Yes
Primary	Change from baseline in major safety endpoints: Kidney Function	Clinically significant differences in the major safety endpoints are defined as: creatinine (>1.5 ULN)	Baseline and Day 7	Yes
Primary	Change from baseline in major safety endpoints: Hepatic Function	Clinically significant differences in the major safety endpoints are defined as: highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN)	Baseline and Day 7	Yes
Secondary	Change from baseline: Glucose	Change from baseline of glucose (mg/dL) as measured from fasting labs collected at Visits 2 and 3.	Baseline and Day 7	No
Secondary	Change from baseline: Insulin	Change from baseline of insulin (uIU/ml) as measured from fasting labs collected at Visits 2 and 3.	Baseline and Day 7	No
Secondary	Change from baseline: C-Peptide	Change from baseline of C-Peptide (ng/mL) as measured from fasting labs collected at Visits 2 and 3.	Baseline and Day 7	No