Ignite Creation Date:
2024-05-06 @ 8:05 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02665117
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2016-01-22
Brief Title:
Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None