Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate
NCT ID: NCT02665117
Last Updated: 2023-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2015-01-31
2022-11-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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KMgCit + Chlorthalidone
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KMgCit for 4 months.
Potassium Magnesium Citrate (KMgCit)
KMgCit will be administer for 4 months with chlorthalidone.
Chlorthalidone
Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
KCl + Chlorthalidone
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KCl for 4 months.
Potassium Chloride (KCl)
KCl will be administer for 4 months with chlorthalidone.
Chlorthalidone
Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
Interventions
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Potassium Magnesium Citrate (KMgCit)
KMgCit will be administer for 4 months with chlorthalidone.
Potassium Chloride (KCl)
KCl will be administer for 4 months with chlorthalidone.
Chlorthalidone
Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Wanpen Vongpatanasin
Professor
Principal Investigators
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Wanpen Vongpatanasin, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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Ahmed LA. Protective effects of magnesium supplementation on metabolic energy derangements in lipopolysaccharide-induced cardiotoxicity in mice. Eur J Pharmacol. 2012 Nov 5;694(1-3):75-81. doi: 10.1016/j.ejphar.2012.07.036. Epub 2012 Aug 23.
Carter BL, Einhorn PT, Brands M, He J, Cutler JA, Whelton PK, Bakris GL, Brancati FL, Cushman WC, Oparil S, Wright JT Jr; Working Group from the National Heart, Lung, and Blood Institute. Thiazide-induced dysglycemia: call for research from a working group from the national heart, lung, and blood institute. Hypertension. 2008 Jul;52(1):30-6. doi: 10.1161/HYPERTENSIONAHA.108.114389. Epub 2008 May 26. No abstract available.
Guerrero-Romero F, Rodriguez-Moran M. Hypomagnesemia, oxidative stress, inflammation, and metabolic syndrome. Diabetes Metab Res Rev. 2006 Nov-Dec;22(6):471-6. doi: 10.1002/dmrr.644.
Hata A, Doi Y, Ninomiya T, Mukai N, Hirakawa Y, Hata J, Ozawa M, Uchida K, Shirota T, Kitazono T, Kiyohara Y. Magnesium intake decreases Type 2 diabetes risk through the improvement of insulin resistance and inflammation: the Hisayama Study. Diabet Med. 2013 Dec;30(12):1487-94. doi: 10.1111/dme.12250. Epub 2013 Jun 29.
Koenig K, Padalino P, Alexandrides G, Pak CY. Bioavailability of potassium and magnesium, and citraturic response from potassium-magnesium citrate. J Urol. 1991 Feb;145(2):330-4. doi: 10.1016/s0022-5347(17)38330-1.
Odvina CV, Mason RP, Pak CY. Prevention of thiazide-induced hypokalemia without magnesium depletion by potassium-magnesium-citrate. Am J Ther. 2006 Mar-Apr;13(2):101-8. doi: 10.1097/01.mjt.0000149922.16098.c0.
Pak CY. Correction of thiazide-induced hypomagnesemia by potassium-magnesium citrate from review of prior trials. Clin Nephrol. 2000 Oct;54(4):271-5.
Price AL, Lingvay I, Szczepaniak EW, Wiebel J, Victor RG, Szczepaniak LS. The metabolic cost of lowering blood pressure with hydrochlorothiazide. Diabetol Metab Syndr. 2013 Jul 9;5(1):35. doi: 10.1186/1758-5996-5-35.
Ruml LA, Pak CY. Effect of potassium magnesium citrate on thiazide-induced hypokalemia and magnesium loss. Am J Kidney Dis. 1999 Jul;34(1):107-13. doi: 10.1016/s0272-6386(99)70115-0.
Vongpatanasin W, Giacona JM, Pittman D, Murillo A, Khan G, Wang J, Johnson T, Ren J, Moe OW, Pak CCY. Potassium Magnesium Citrate Is Superior to Potassium Chloride in Reversing Metabolic Side Effects of Chlorthalidone. Hypertension. 2023 Dec;80(12):2611-2620. doi: 10.1161/HYPERTENSIONAHA.123.21932. Epub 2023 Oct 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STU 092015-058
Identifier Type: -
Identifier Source: org_study_id
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