Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:5/11/2018
Start Date:January 2015
End Date:January 2019
Contact:Debbie Arbique, DNP
Email:debbie.arbique@utsouthwestern.edu
Phone:(214)648-3188

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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.

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.

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.

- Claustrophobia

- Metal implants
We found this trial at
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sites
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Wanpen Vongpatanasin, MD
Phone: 214-648-2103
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Wanpen Vongpatanasin, MD
Phone: 214-648-2968
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Phone: 214-648-3188
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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