search
Back to results

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

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
epicatechin
Placebo
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-diabetes focused on measuring epicatechin, pre-diabetes

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CMR Center for Metabolic Research VASDHS
  • VA San Diego Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

(+)-epicatechin 30mg

placebo

Arm Description

10 subjects will be randomized to a 30mg dose of synthetic (+)-epicatechin

5 subjects will be randomized to a placebo

Outcomes

Primary Outcome Measures

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)
Change from baseline in major safety endpoints: Heart Rate (HR)
Clinically significant differences in the major safety endpoints are defined as: HR (10 bpm)
Change from baseline in major safety endpoints: Kidney Function
Clinically significant differences in the major safety endpoints are defined as: creatinine (>1.5 ULN)
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)

Secondary Outcome Measures

Change from baseline: Glucose
Change from baseline of glucose (mg/dL) as measured from fasting labs collected at Visits 2 and 3.
Change from baseline: Insulin
Change from baseline of insulin (uIU/ml) as measured from fasting labs collected at Visits 2 and 3.
Change from baseline: C-Peptide
Change from baseline of C-Peptide (ng/mL) as measured from fasting labs collected at Visits 2 and 3.

Full Information

First Posted
January 7, 2016
Last Updated
April 26, 2016
Sponsor
Veterans Medical Research Foundation
Collaborators
San Diego Veterans Healthcare System, National Center for Complementary and Integrative Health (NCCIH), University of California, San Diego, National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT02656212
Brief Title
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
Acronym
Epicatechin
Official Title
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
San Diego Veterans Healthcare System, National Center for Complementary and Integrative Health (NCCIH), University of California, San Diego, National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
epicatechin, pre-diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(+)-epicatechin 30mg
Arm Type
Experimental
Arm Description
10 subjects will be randomized to a 30mg dose of synthetic (+)-epicatechin
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
5 subjects will be randomized to a placebo
Intervention Type
Drug
Intervention Name(s)
epicatechin
Other Intervention Name(s)
122158
Intervention Description
30 mg (+)-epicatechin, taken orally, one pill/day in the morning
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pill, taken orally, one pill/day in the morning
Primary Outcome Measure Information:
Title
Change from baseline in major safety endpoints: Blood Pressure (BP)
Description
Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change)
Time Frame
Baseline and Day 7
Title
Change from baseline in major safety endpoints: Heart Rate (HR)
Description
Clinically significant differences in the major safety endpoints are defined as: HR (10 bpm)
Time Frame
Baseline and Day 7
Title
Change from baseline in major safety endpoints: Kidney Function
Description
Clinically significant differences in the major safety endpoints are defined as: creatinine (>1.5 ULN)
Time Frame
Baseline and Day 7
Title
Change from baseline in major safety endpoints: Hepatic Function
Description
Clinically significant differences in the major safety endpoints are defined as: highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN)
Time Frame
Baseline and Day 7
Secondary Outcome Measure Information:
Title
Change from baseline: Glucose
Description
Change from baseline of glucose (mg/dL) as measured from fasting labs collected at Visits 2 and 3.
Time Frame
Baseline and Day 7
Title
Change from baseline: Insulin
Description
Change from baseline of insulin (uIU/ml) as measured from fasting labs collected at Visits 2 and 3.
Time Frame
Baseline and Day 7
Title
Change from baseline: C-Peptide
Description
Change from baseline of C-Peptide (ng/mL) as measured from fasting labs collected at Visits 2 and 3.
Time Frame
Baseline and Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert R Henry, MD
Organizational Affiliation
San Diego Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMR Center for Metabolic Research VASDHS
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs