N/A
N=61
Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02665117 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Change in Fasting Plasma Glucose From Week 4 to Week 16 — -5.6; 2.3 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Potassium Magnesium Citrate (KMgCit) (Drug); Potassium Chloride (KCl) (Drug); Chlorthalidone (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fasting Plasma Glucose From Week 4 to Week 16 |
-5.6; 2.3 | — |
| SECONDARY Chang in Hepatic Fat Measured at Baseline and Week 16 |
0.31; 1.59 | — |
| SECONDARY Change in Muscle Magnesium Content Measured at Baseline and Week 16 |
-0.01; 0.02 | — |
| SECONDARY Change in FGF23 From Week 4 to Week 16 |
38.1; 13.6 | — |
Summary
Chlorthalidone (CTD) may produce various metabolic disturbances, including hypokalemia, activation of Renin-Angiotensin- Aldosterone (RAA) system, oxidative stress, dyslipidemia, Fibroblast growth factor 23 (FGF23) synthesis, and magnesium depletion. These factors may interact with each other to contribute to the development of insulin resistances and metabolic syndrome. Smaller studies have suggested that Potassium magnesium Citrate (KMgCit) can ameliorate CTD- induced metabolic side effects independent of correction of hypokalemia. This study will tests if KMgCit ameliorates CTD induced metabolic effects independent of correction of hypokalemia.
Eligibility Criteria
Inclusion Criteria
- Treated or untreated stage I hypertension
Exclusion Criteria
- Diabetes mellitus,
- Renal impairment (serum creatinine > 1.4 mg/dL),
- Any heart diseases such as congestive heart failure, sustained arrhythmia, or coronary heart disease,
- Chronic regular NSAID use,
- Allergy to thiazide diuretics,
- Gastro-esophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week,
- Esophageal-gastric ulcer or history of gastrointestinal bleeding,
- Chronic diarrhea, vomiting,
- Excessive sweating,
- Unprovoked hypokalemia (serum K 5.3 mmol/L),
- Abnormal liver function test (Aspartate transaminase (AST) or Alanine transaminase (ALT) above upper limit of normal range),
- Subjects on any potassium supplement on a regular basis for any reason, such as patients with primary aldosteronism,
- Pregnancy,
- History of major depression, bipolar disorder, or schizophrenia,
- History of substance abuse,
- Gout,
- Metabolic alkalosis, with serum bicarbonate > 32 meq/L,
- Severe dietary salt restriction, less than1/2 spoonful or 50 meq sodium/day.
- Patient with Claustrophobia will not have MRI but can still participate in the study without MRI
- Metal implants will not have MRI but can still participate in the study without MRI
Data sourced from ClinicalTrials.gov (NCT02665117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.