Ignite Creation Date:
2024-05-06 @ 9:03 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02891954
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-09-26
First Post:
2016-08-30
Brief Title:
Genetics of Response to Canagliflozin
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Pharmacogenomics to Predict Responses to SGLT2 Inhibitors
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-09
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:
Five daily doses of canagliflozin 300 mg will be administered to healthy volunteers Pharmacodynamic responses to canagliflozin will be assessed both at 2 days and 6 days after administration of the first dose of canagliflozin A genome-wide association study GWAS will be conducted to search for genetic variants that are associated with each of the pharmacodynamic responses to canagliflozin
Detailed Description:
After obtaining informed consent healthy Amish research subjects will be screened for eligibility Immediately after obtaining blood samples for baseline clinical chemistry tests wills patients will initiate 5 days of canagliflozin 300 mg treatment Fasting blood samples will be obtained to assess pharmacodynamic responses at both 48 hours and 120 hours after initiating canagliflozin The principal pharmacodynamic responses will include 24 hour urinary excretion of glucose serum chemistries phosphorus FGF23 125-dihydroxyvitamin D parathyroid hormone PTH glucagon beta-hydroxybutyrate acetoacetate procollagen type I N-terminal peptide P1NP and beta-CTX Research subjects will undergo genotyping and a genome-wide association study will be conducted to search for genetic variants that are associated with pharmacodynamic responses to canagliflozin
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK118942 | NIH | None | httpsreporternihgovquickSearchR01DK118942 |