NCT02656212

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

January 7, 2016

Last Update Submit

April 26, 2016

Conditions

Pre-diabetes

Keywords

epicatechinpre-diabetes

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (3)

  • Change from baseline: Glucose

    Baseline and Day 7

  • Change from baseline: Insulin

    Baseline and Day 7

  • Change from baseline: C-Peptide

    Baseline and Day 7

Study Arms (2)

(+)-epicatechin 30mg

EXPERIMENTAL

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

Drug: epicatechin

placebo

PLACEBO COMPARATOR

5 subjects will be randomized to a placebo

Drug: Placebo

Interventions

epicatechinDRUG

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

Also known as: 122158
(+)-epicatechin 30mg
PlaceboDRUG

Placebo pill, taken orally, one pill/day in the morning

placebo

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CMR Center for Metabolic Research VASDHS

San Diego, California, 92161, United States

Location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Catechin

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChromansBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFlavonoidsChromonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Robert R Henry, MD

    San Diego Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Section of Diabetes, Endocrinology and Metabolism

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 14, 2016

Study Start

September 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

US(2)