The Effects of Potassium on Glucose Metabolism in African Americans
Public ClinicalTrials.gov record NCT02236598. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 metabolism with a 3-hour oral glucose tolerance test (OGTT), baseline chemistries and a baseline 24-hour urinary potassium measurement. Patients will take the intervention daily and will undergo repeat testing of all of these measures at the end of a 3 month period. The primary endpoint will be change in glucose tolerance, as measured by change in glucose area-under-the-curve (AUC) of a 3-hour oral glucose tolerance test (OGTT). Secondary endpoints will include changes in fasting, 1-hour, and 2-hour post-challenge glucose levels, as well as measurements of insulin secretion and insulin sensitivity as measures by the oral glucose minimal model method.(1) The baseline data from this trial will allow us to quantify abnormalities in glucose metabolism in African Americans with prediabetes/early diabetes and low-normal serum K. The post-intervention data will provide estimates of the impact of K-supplements compared to no supplements on these abnormalities. Data derived from the pilot study will be used in the design of a larger scale, adequately powered clinical trial. This trial will also help to assess the feasibility of recruiting this target population. With this pilot trial, we will begin to determine whether or not K-supplements, an inexpensive, well-tolerated, and simple intervention, could help to reduce diabetes risk among African Americans.
Study identification
- NCT ID
- NCT02236598
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2014
- Primary completion
- Feb 28, 2016
- Completion
- Feb 28, 2016
- Last update posted
- May 22, 2017
2015 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02236598, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 22, 2017 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02236598 live on ClinicalTrials.gov.