| Trial ID: | L3315 |
| Source ID: | NCT03283566
|
| Associated Drug: |
Hydroxychloroquine
|
| Title: |
Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03283566/results
|
| Conditions: |
Chronic Pancreatitis|Insulin Dependent Diabetes
|
| Interventions: |
DRUG: Hydroxychloroquine|DRUG: Placebo
|
| Outcome Measures: |
Primary: Quotient of Stimulated C-peptide/Glucose Level Normalized for IEQ/Kg Infused in Response to MMTT, 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., 12 months | Secondary: C-peptide AUC Response to MMTT, 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., 12 months|Ratio of C-peptide AUC to Glucose AUC in Response to MMTT Adjusted for Infused Islet Cell Mass, 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., 12 months
|
| Sponsor/Collaborators: |
Sponsor: The Cleveland Clinic | Collaborators: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)|Stanford University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
9
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-10-03
|
| Completion Date: |
2020-05-31
|
| Results First Posted: |
2022-03-11
|
| Last Update Posted: |
2022-04-08
|
| Locations: |
Cleveland Clinic, Cleveland, Ohio, 44195, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03283566
|
