Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-08 @ 5:29 PM
Study NCT ID:
NCT02768220
Status:
WITHDRAWN
Last Update Posted:
2018-02-15
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products
Sponsor:
Northwell Health
Organization:
Study Overview
Official Title:
The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products
Status:
WITHDRAWN
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single-center open-label multiple dose randomized two period cross-over study to examine Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin administration.
Detailed Description:
Single-center open-label multiple dose randomized two period cross-over study.
The North-Shore Long Island Jewish Institutional Review Board will be used to approve our study protocol.
All patients will give written informed consent and comply with the Helsinki agreement and good clinical practices guidelines.
Treatment Plan:
Eligible patients will be randomized to receive linagliptin 5mg daily or empagliflozin 25mg daily for 30 days followed by a 30 day washout period and crossover. All pre-existing diabetic medications will continue unchanged.
Fasting blood carboxymethyl lysine (CML), methylglyoxal (MG), vascular cell adhesion molecule (VCAM), tumor necrosis factor (TNF) alpha, 8-isoprostane, and routine chemistries and urinary CML, MG, and creatinine will be measured at baseline, after 30 days, 60 days and 90 days.
AGE levels will be measured by Elisa.
The North-Shore Long Island Jewish Institutional Review Board will be used to approve our study protocol.
All patients will give written informed consent and comply with the Helsinki agreement and good clinical practices guidelines.
Treatment Plan:
Eligible patients will be randomized to receive linagliptin 5mg daily or empagliflozin 25mg daily for 30 days followed by a 30 day washout period and crossover. All pre-existing diabetic medications will continue unchanged.
Fasting blood carboxymethyl lysine (CML), methylglyoxal (MG), vascular cell adhesion molecule (VCAM), tumor necrosis factor (TNF) alpha, 8-isoprostane, and routine chemistries and urinary CML, MG, and creatinine will be measured at baseline, after 30 days, 60 days and 90 days.
AGE levels will be measured by Elisa.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: