Trial · NCT03283566
Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT
NCT03283566, Phase 2, Completed, The Cleveland Clinic; results first posted 2022-03-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT. Trials, record NCT03283566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03283566
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT
- NCT number
- NCT03283566
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Chronic Pancreatitis, Insulin Dependent Diabetes
- Interventions
- Hydroxychloroquine, Placebo
- First posted
- 2017-09-14
- Last updated
- 2022-04-08
- Results first posted
- 2022-03-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Quotient of Stimulated C-peptide/Glucose Level Normalized for IEQ/Kg Infused in Response to MMTT | 12 months | HCQ-treated compared to placebo arm. This outcome measure was reported in Mean and Standard deviation looking at C peptide/glucose secretion at 90 mins during mixed meal test adjusted for IEG/Kg (islet cell equivalency) infused to the patient. |
| Secondary | C-peptide AUC Response to MMTT | 12 months | HCQ-treated compared to placebo arm. We used a standard, 5 hour Mixed meal tolerance test (MMT). Blood draws were taken every 15 mins for the first hours, then every 30 mins the second hour, then hourly until completion. |
| Secondary | Ratio of C-peptide AUC to Glucose AUC in Response to MMTT Adjusted for Infused Islet Cell Mass | 12 months | C-peptide, ng/mL/min/IEQ/kg iAUC post-MMTT. Our measurement can be reported in area under the curve for C-peptide normalized for glucose values as well as Islet cell mass infused to the patient in order to compare placebo vs intervention arms. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Quotient of Stimulated C-peptide/Glucose Level Normalized for IEQ/Kg Infused in Response to MMTT | 12 months | C-peptide/Glucose = ng/mg glucose/IEQ/kg - Primary 12-month endpoint | ng/mg glucose/IEQ/kg | MEAN |
| SECONDARY | C-peptide AUC Response to MMTT | 12 months | ng/mL/min | MEAN | |
| SECONDARY | Ratio of C-peptide AUC to Glucose AUC in Response to MMTT Adjusted for Infused Islet Cell Mass | 12 months | Treatment versus placebo | ng/mL/min/IEQ/kg iAUC post-MMT | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Quotient of Stimulated C-peptide/Glucose Level Normalized for IEQ/Kg Infused in Response to MMTT | Hydroxychloroquine | .000000077 | Standard Deviation .000000096 | ng/mg glucose/IEQ/kg | |
| Quotient of Stimulated C-peptide/Glucose Level Normalized for IEQ/Kg Infused in Response to MMTT | Placebo | 0.000000079 | Standard Deviation .00000012 | ng/mg glucose/IEQ/kg | |
| C-peptide AUC Response to MMTT | Hydroxychloroquine | 813 | Standard Deviation 463 | ng/mL/min | |
| C-peptide AUC Response to MMTT | Placebo | 588 | Standard Deviation 391 | ng/mL/min | |
| Ratio of C-peptide AUC to Glucose AUC in Response to MMTT Adjusted for Infused Islet Cell Mass | Hydroxychloroquine | 0.00091 | Standard Deviation 0.0006 | ng/mL/min/IEQ/kg iAUC post-MMT | |
| Ratio of C-peptide AUC to Glucose AUC in Response to MMTT Adjusted for Infused Islet Cell Mass | Placebo | 0.00222 | Standard Deviation 0.0029 | ng/mL/min/IEQ/kg iAUC post-MMT |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydroxychloroquine | 4 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | COMPLETED | Hydroxychloroquine | 3 | |
| Overall Study | COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Hydroxychloroquine | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydroxychloroquine | 0 | 3 |
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, other adverse events | Hydroxychloroquine | 0 | 3 |
| Total, other adverse events | Placebo | 0 | 3 |
| Total, serious adverse events | Hydroxychloroquine | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 3 |
Source ClinicalTrials.gov
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hydroxychloroquine vs Placebo: deaths from any cause | Trial comparisons |
| Hydroxychloroquine vs Placebo: serious adverse events | Trial comparisons |
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/NCT03283566
GET https://conductscience.org/api/trials/v1/NCT03283566/registered