The Effects of Potassium on Glucose Metabolism in African Americans
Borderline Hypokalemia
About this trial
This is an interventional treatment trial for Borderline Hypokalemia focused on measuring borderline hypokalemia, glucose tolerance, insulin secretion, insulin sensitivity, fasting glucose, African American
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
K+ supplementation
Placebo
K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, United States Pharmacopeia (USP) equivalent to 10 milliequivalent (mEq) of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months Subjects will be instructed to take the pills