Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT07167693
Description:
We will share de-identified individual participant data (IPD) underlying the primary and secondary outcomes, including: demographics (age, sex), baseline clinical values, all C-peptide and glucose measurements at 0/10/30/90 minutes, β-hydroxybutyrate values used to derive ketone-clearance metrics, total insulin administered in the first 24 hours, adverse events, and (when available) amino-acid measures and platelet mitochondrial assays. A data dictionary will accompany the dataset. All IPD will be de-identified consistent with HIPAA Safe Harbor (direct identifiers removed; dates converted to study day/time; site identifiers suppressed).
Study:
NCT07167693
Study Brief:
Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes