Pre-diabetesPhase 1EpicatechinNCT02656212
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
A Phase 1 study testing epicatechin in people with Pre-diabetes, run by Veterans Medical Research Foundation at 2 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- epicatechin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CMR Center for Metabolic Research VASDHS
San Diego, California, 92161
VA San Diego Healthcare System
San Diego, California, 92161
About this study
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
Read the 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.
- Conditions
- Pre-diabetes
- Being tested
- epicatechin, Placebo
- Keywords
- epicatechin, pre-diabetes
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epicatechinDrug
Also called 122158
30 mg (+)-epicatechin, taken orally, one pill/day in the morning
PlaceboDrug
Placebo pill, taken orally, one pill/day in the morning
| Study group | Role | What they receive |
|---|---|---|
| (+)-epicatechin 30mg | Experimental | 10 subjects will be randomized to a 30mg dose of synthetic (+)-epicatechin Receives: Drug: epicatechin |
| placebo | Placebo comparator | 5 subjects will be randomized to a placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline and Day 7
Secondary outcomes (3)
Change from baseline: Glucose
Change from baseline of glucose (mg/dL) as measured from fasting labs collected at Visits 2 and 3.
Measured: Baseline and Day 7
Change from baseline: Insulin
Change from baseline of insulin (uIU/ml) as measured from fasting labs collected at Visits 2 and 3.
Measured: Baseline and Day 7
Change from baseline: C-Peptide
Change from baseline of C-Peptide (ng/mL) as measured from fasting labs collected at Visits 2 and 3.
Measured: Baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego Veterans Healthcare System, National Center for Complementary and Integrative Health (NCCIH), University of California, San Diego, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Robert R. Henry, MD, Veterans Medical Research Foundation
- Investigators
- Robert R Henry, MD, Principal investigator, San Diego Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656212
- Sponsor's protocol ID
- 08847002
- Other IDs
- 1R01AT008310-01
- Acronym
- Epicatechin
- Status last verified
- Apr 2016
- First submitted
- 7 Jan 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
- ClinicalTrials.gov ID
- NCT02656212
- Acronym / sponsor ID
- Epicatechin / 08847002
- Conditions
- Pre-diabetes
- Keywords
- epicatechin, pre-diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- San Diego Veterans Healthcare System, National Center for Complementary and Integrative Health (NCCIH), University of California, San Diego, National Institutes of Health (NIH)
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (+)-epicatechin 30mg | Experimental | Drug: epicatechin10 subjects will be randomized to a 30mg dose of synthetic (+)-epicatechin |
| placebo | Placebo comparator | Drug: Placebo5 subjects will be randomized to a placebo |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epicatechinAlso: 12215830 mg (+)-epicatechin, taken orally, one pill/day in the morning | Drug | (+)-epicatechin 30mg |
| PlaceboPlacebo pill, taken orally, one pill/day in the morning | Drug | placebo |
Primary outcome
Change from baseline in major safety endpoints: Blood Pressure (BP)
Time frame: Baseline and Day 7
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)
Time frame: Baseline and Day 7
Clinically significant differences in the major safety endpoints are defined as: HR (10 bpm)
Change from baseline in major safety endpoints: Kidney Function
Time frame: Baseline and Day 7
Clinically significant differences in the major safety endpoints are defined as: creatinine (>1.5 ULN)
Change from baseline in major safety endpoints: Hepatic Function
Time frame: Baseline and Day 7
Clinically significant differences in the major safety endpoints are defined as: highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN)
3 secondary outcomes
Change from baseline: Glucose
Time frame: Baseline and Day 7
Change from baseline: Insulin
Time frame: Baseline and Day 7
Change from baseline: C-Peptide
Time frame: Baseline and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert R Henry, MD principal investigator
San Diego Veterans Healthcare System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing epicatechin in people with Pre-diabetes, run by Veterans Medical Research Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in major safety endpoints: Blood Pressure (BP) (time frame: Baseline and Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.