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Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02665117
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : February 16, 2023
Sponsor:
Information provided by (Responsible Party):
Wanpen Vongpatanasin, University of Texas Southwestern Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Potassium Magnesium Citrate (KMgCit) Drug: Potassium Chloride (KCl) Drug: Chlorthalidone Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate
Study Start Date : January 2015
Actual Primary Completion Date : November 4, 2022
Actual Study Completion Date : November 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Drug: Potassium Magnesium Citrate (KMgCit)
KMgCit will be administer for 4 months with chlorthalidone.
Other Name: KMgCit

Drug: 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.
Active Comparator: 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.
 Drug: Potassium Chloride (KCl)
KCl will be administer for 4 months with chlorthalidone.
Other Name: KCl

Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in fasting plasma glucose [ Time Frame: 4 months ]
    Will be measured from venous blood sample


Secondary Outcome Measures :
  1. Hepatic fat [ Time Frame: 4 months ]
    Will be measured using hepatic magnetic resonance imaging

  2. Muscle magnesium content [ Time Frame: 4 months ]
    Will be measured using magnetic resonance imaging.

  3. Serum Aldosterone [ Time Frame: 4 months ]
    Will be measured from serum sample

  4. FGF23 [ Time Frame: 4 months ]
    Will be measured from serum sample

  5. Urinary Isoprostanes [ Time Frame: 4 months ]
    Will be measured before and after treatment regimen containing potassium salt.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665117


Locations
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United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Wanpen Vongpatanasin, MD UT Southwestern Medical Center
More Information
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Publications:

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Responsible Party: Wanpen Vongpatanasin, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02665117    
Other Study ID Numbers: STU 092015-058
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: February 16, 2023
Last Verified: February 2023
Keywords provided by Wanpen Vongpatanasin, University of Texas Southwestern Medical Center:
Hypokalemia
Isoprostanes
Insulin resistance
Aldosterone
 Hepatic fat
Muscle Magnesium
Liver fat
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Chlorthalidone
Magnesium citrate
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
 Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Cathartics
Gastrointestinal Agents