Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate

  • STATUS
    Recruiting
  • End date
    Jan 24, 2023
  • participants needed
    60
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 24 March 2021
insulin
hypertension
metabolic syndrome
aldosterone
potassium
diuretics
thiazide
angiotensin
renin
dyslipidemia
chlorthalidone

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.

Description

CTD- induced metabolic side effects were though to be dependent on hypokalemia, but subsequent studies suggested that CTD - induced side effects were independent from hypokalemia. On the other hand, magnesium depletion has been linked to increased Renin-Angiotensin- Aldosterone (RAA) system, the development of metabolic syndrome and insulin resistance with magnesium supplementation ameliorating these effects.

Participants will participate in a double-blinded, parallel design study. After baseline evaluation participants will take Chlorthalidone (CTD) alone for 2-3 weeks. They will then be randomized to two equal groups to take KMgCit powder or Potassium Chloride (KCl) powder along with CTD for 4 months.

We speculate that Mg depletion is responsible for hepatic fat deposition, which then produces insulin resistance. Co-administration of KMgCit powder would avert magnesium (Mg) depletion, block hepatic fat deposition by restoring normal Mg status and direct intestinal binding of fat, thereby ameliorating insulin resistance. To test this hypothesis, we shall quantitate muscle Mg status and hepatic fat content by magnetic resonance spectroscopy (MRS) before and after KMgCit. Change in fasting glucose, insulin resistance, serum potassium, FGF23, and aldosterone will be compared between KCL and KMgCit groups after 4 months.

Details
Condition Vascular Diseases, Hypertension, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Elevated Blood Pressure, high blood pressure, arterial hypertension
Treatment chlorthalidone, Potassium Magnesium Citrate (KMgCit), Potassium Chloride (KCl)
Clinical Study IdentifierNCT02665117
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on24 March 2021

Eligibility

Yes No Not Sure

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 < 3.5 mmol/L) or hyperkalemia (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
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