Clinical trial

Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate

Name
STU 092015-058
Description
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.
Trial arms
Trial start
2015-01-01
Estimated PCD
2022-11-04
Trial end
2022-11-04
Status
Completed
Treatment
Potassium Magnesium Citrate (KMgCit)
KMgCit will be administer for 4 months with chlorthalidone.
Arms:
KMgCit + Chlorthalidone
Other names:
KMgCit
Potassium Chloride (KCl)
KCl will be administer for 4 months with chlorthalidone.
Arms:
KCl + Chlorthalidone
Other names:
KCl
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.
Arms:
KCl + Chlorthalidone, KMgCit + Chlorthalidone
Size
61
Primary endpoint
Change in Fasting Plasma Glucose From Week 4 to Week 16
week 4 and week 16
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 \< 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 61, 'type': 'ACTUAL'}}
Updated at
2023-10-25

1 organization

3 products

1 indication

Indication
Hypertension