Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT008310-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| San Diego Veterans Healthcare System | FED |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| University of California, San Diego | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
This project is a double-blinded, placebo-controlled, randomized, Phase I study that will include (+)-epicatechin dosing over seven days.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (+)-epicatechin 30mg | Experimental | 10 subjects will be randomized to a 30mg dose of synthetic (+)-epicatechin |
|
| placebo | Placebo Comparator | 5 subjects will be randomized to a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epicatechin | Drug | 30 mg (+)-epicatechin, taken orally, one pill/day in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline: Insulin | Change from baseline of insulin (uIU/ml) as measured from fasting labs collected at Visits 2 and 3. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert R Henry, MD | San Diego Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMR Center for Metabolic Research VASDHS | San Diego | California | 92161 | United States | ||
| VA San Diego Healthcare System |
Not provided
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002392 | Catechin |
| ID | Term |
|---|---|
| D002839 | Chromans |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| National Institutes of Health (NIH) |
| NIH |
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo pill, taken orally, one pill/day in the morning |
|
| 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. | Baseline and Day 7 |
| San Diego |
| California |
| 92161 |
| United States |
| D006571 |
| Heterocyclic Compounds |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |