Pre-diabetes Clinical Trial
Official title:
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
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.
- 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Enrolling by invitation |
NCT05367024 -
Broccoli Effect on Glycated Haemoglobin (HbA1c)
|
N/A | |
| Withdrawn |
NCT02400450 -
Designer Functional Foods on Parameters of Metabolic and Vascular in Prediabetes
|
N/A | |
| Completed |
NCT02933424 -
Project Plant Protein: the P3 Study in Humans
|
N/A | |
| Completed |
NCT02330276 -
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
|
Phase 1 | |
| Completed |
NCT01488279 -
Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy
|
N/A | |
| Completed |
NCT00831129 -
A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs
|
Phase 2/Phase 3 | |
| Completed |
NCT00536250 -
Study to Investigate the Pathophysiology of Type 2 Diabetes in Youth
|
N/A | |
| Recruiting |
NCT05563090 -
Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
|
||
| Active, not recruiting |
NCT04991142 -
Models of Nutrition From Continuous Glucose Monitors
|
||
| Completed |
NCT02759055 -
Pre-Diabetes Cardiovascular (CV) Care (Pre-Diabetes Wizard)
|
N/A | |
| Completed |
NCT00775684 -
Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
|
N/A | |
| Completed |
NCT03695913 -
Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
|
N/A | |
| Completed |
NCT04051008 -
CTSI Pilot: Improving Adherence to Diabetic Diet
|
N/A | |
| Recruiting |
NCT04897945 -
A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus
|
N/A | |
| Not yet recruiting |
NCT04442451 -
Mechanisms of Fatigability With Diabetes
|
N/A | |
| Not yet recruiting |
NCT05925933 -
High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes
|
N/A | |
| Active, not recruiting |
NCT05654051 -
The SLIM LIVER Study
|
Phase 2 | |
| Completed |
NCT02919397 -
Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
|
N/A | |
| Completed |
NCT00589459 -
Gender Differences in Prevalence of Undiagnosed Diabetes in ACS
|