Trial · NCT07167693
Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes
NCT07167693, Phase 1, Phase 2, Recruiting, David K Carroll
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes. Trials, record NCT07167693. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07167693
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes
- NCT number
- NCT07167693
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- David K Carroll
- Conditions
- Diabetes (DM), Diabetic Ketoacidosis, Ketosis Prone Diabetes, Hyperglycaemia (Diabetic)
- Interventions
- Arginine hydrochloride, Sodium Chloride 0.9%
- First posted
- 2025-09-11
- Last updated
- 2026-02-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in endogenous insulin secretion (C-peptide/glucose ratio) | Baseline (pre-infusion) to 90 minutes after infusion start | Serum C-peptide (ng/mL) and plasma glucose (mg/dL) will be measured at 0 (pre-infusion), 10, 30, and 90 minutes from infusion start. The C-peptide/glucose ratio will be calculated at each time. Primary summary = change from baseline to 90 minutes (90-min ratio minus baseline ratio). Higher values indicate greater recruitable endogenous insulin secretion. |
| Secondary | Change in beta-hydroxybutyrate (BHB) concentration | Baseline to 24 hours | Difference in serum BHB from baseline to 24 hours (baseline BHB minus 24-hour BHB). Positive values reflect ketone clearance. |
| Secondary | Rate of BHB clearance | 0-24 hours | Slope of BHB concentration over time using all clinically obtained values in the first 24 hours. |
| Secondary | Total insulin administered in first 24 hours | 0-24 hours | Sum of all insulin doses (IV and/or subcutaneous) administered as part of routine care. |
| Secondary | Plasma arginine concentration (change from baseline) | Baseline to 90 minutes | HPLC-based quantification of plasma arginine at baseline and 90 minutes; change = 90-min minus baseline. |
| Secondary | Global Arginine Bioavailability Ratio (GABR) | Baseline to 90 minutes | GABR = \[arginine\]/(\[ornithine\]+\[citrulline\]); change from baseline to 90 minutes. |
| Other | Platelet mitochondrial complex IV activity (change from baseline) | Baseline to 90 minutes | Enzymatic activity of cytochrome c oxidase (complex IV) measured in isolated platelet-rich plasma; normalized to protein content or citrate synthase as per lab SOP; change = 90-min minus baseline. |
| Other | Platelet mitochondrial complex V (ATP synthase) activity (change from baseline) | Baseline to 90 minutes | Activity measured in isolated platelets; normalized per lab SOP; change = 90-min minus baseline. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07167693
GET https://conductscience.org/api/trials/v1/NCT07167693/registered