Status:
COMPLETED
The Effects of Potassium on Glucose Metabolism in African Americans
Lead Sponsor:
Duke University
Conditions:
Borderline Hypokalemia
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- To be eligible for inclusion in the study the following enrollment criteria must be met:
- Participants must be 30 years of age or older.
- They must have a diagnosis of prediabetes defined as a hemoglobin A1c between 5.7-6.5% measured at the initial screening visit.
- They must have a serum K+ of 3.3-4.0 mEq/L on 2 occasions, within a 18 month period, including at initial screening visit. If subject is just outside range for inclusion, PI may offer the subject the option to repeat their screening serum K+ measurement.
- The participant must be willing and capable of providing written informed consent.
- The participant must be available for follow-up and must at minimum have telephone access.
- Participants must be able to read/understand English.
Exclusion
- Participants must not have any of the following:
- Participants must not have evidence of chronic kidney disease with an estimated Glomerular Filtration Rate (eGFR) \< 60ml/min. All patients will be screened for eGFR at the enrollment visit.
- Participants must not have evidence of diabetes mellitus requiring treatment with medications prior to screening visit. The cannot have a random or post-challenge glucose ≥ 200mg/dl (from prior labs), A1c level ≥ 6.5% (from prior labs), prior physician diagnosis, or use of anti-diabetic medications. If participants have glucose levels in the diabetic range at screening visit, they will be eligible to continue in study as long as glucose levels are not \> 200 mg/dl.
- Participants must not have a history of endoscopy-verified peptic ulcer disease with past history of either gastric or duodenal ulcer.
- Participants must not have evidence of cardiac arrhythmias, unstable angina or cardiac event within 6 months, congestive heart failure, or other conditions that might impact follow-up, based on the discretion of the principal investigator.
- Participants must not be pregnant or intend to get pregnant during the study period. The study intervention is safe for pregnant women, so serum pregnancy screening is not indicated; however, pregnant women are excluded because pregnancy affects glucose homeostasis, which will bias primary outcome measurement and damage scientific validity of the study.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2016
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT02236598
Start Date
January 1 2015
End Date
February 29 2016
Last Update
May 23 2017
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710