Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT02768220
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.
Study:
NCT02768220
Study Brief:
Protocol Section:
NCT02768220