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NCT02236598 · ClinicalTrials.gov registry record · Phase 2
The Effects of Potassium on Glucose Metabolism in African Americans
A Phase 2 study of Borderline Hypokalemia, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT02236598 is a Phase 2 study of Borderline Hypokalemia that has completed, run by Duke University. The registered enrollment target is 61 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02236598, a Phase 2 study of Borderline Hypokalemia, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
African Americans suffer a disproportionately high risk of diabetes compared to other Americans. Reasons for race disparities in diabetes incidence are not completely understood. Although a difference in prevalence of obesity does explain a significant portion of the racial disparity in diabetes risk, it does not explain all of this disparity. Strategies to control the diabetes epidemic and reduce its racial disparity often overlook preventive measures. Currently, the most powerful known strategy for preventing diabetes is weight loss in the overweight/obese. However, because weight loss is often difficult to achieve and maintain, other opportunities to prevent diabetes should be identified, particularly in African Americans. Among potential novel opportunities is correction of low or low-normal potassium levels (hypokalemia). In secondary analyses, we have found low-normal potassium (K) to be a novel risk factor for diabetes; and we have found that this association between low-K and diabetes risk may be stronger in African Americans compared to whites. Therefore, a previously unrecognized alternative or adjunct strategy for preventing diabetes, particularly in African Americans, may involve correction of low or low-normal K levels (hypokalemia). Large-scale, adequately-powered, randomized controlled trials are needed to establish the effectiveness of this approach. However, prior to those trials, the pathophysiology of the association between low K and poor glucose metabolism must be understood. This pilot clinical trial will begin to determine the effect of K supplementation on measures of glucose metabolism in African Americans. In this pilot clinical trial, 30 African Americans with prediabetes and a low-normal serum K \[\<4.0 milliequivalent/Liter (Eq/L)\] will be randomized to K-supplements, 20mEq (2-10mEq tablets) twice daily or a matching placebo capsules twice daily. Prior to randomization, baseline measures will be taken including measures of glucose meta
Conditions Studied
Interventions
- DRUG Placebo
- DRUG K+ supplement
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-02-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02236598
The ClinicalTrials.gov registry entry for NCT02236598 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Borderline Hypokalemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02236598 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02236598 about?
NCT02236598 is a clinical study titled "The Effects of Potassium on Glucose Metabolism in African Americans". African Americans suffer a disproportionately high risk of diabetes compared to other Americans. Reasons for race disparities in diabetes incidence are not completely understood. Although a difference in prevalence of obesity does explain a significant portion of the racial disparity in diabetes ris...
What is the current status of trial NCT02236598?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2015-01. Estimated completion is 2016-02-29.
What conditions does trial NCT02236598 study?
This clinical trial studies the following conditions: Borderline Hypokalemia.
What interventions are being tested in trial NCT02236598?
The interventions under investigation include: Placebo (DRUG), K+ supplement (DRUG).
Who is sponsoring clinical trial NCT02236598?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02236598 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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