| Trial ID: | L4339 |
| Source ID: | NCT05266963
|
| Associated Drug: |
Creon
|
| Title: |
Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes
|
| Acronym: |
CREON
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT05266963/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: CREON|DRUG: Placebo
|
| Outcome Measures: |
Primary: Improvement in Glucose Regulation, Mixed meal tolerance testing (MMTT) will be used to assess glucose regulation via c-peptide AUC at baseline, and after treatment with placebo and CREON in a random order., through study completion (4-5 weeks)|Patient-reported Change in Pancreatic Exocrine Insufficiency (PEI) Symptoms, We will use the pancreatic exocrine insufficiency questionnaire (PEI-Q) to quantitate symptoms of PEI and their relative change from baseline to after treatment with placebo and Creon in a random order. Minimum score is 0, and maximum score is 4. Higher scores correlate to worse outcome, i.e., increased abdominal symptoms and bowel movement symptoms., through study completion (4-5 weeks) |
|
| Sponsor/Collaborators: |
Sponsor: Vanderbilt University Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
11
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-09-02
|
| Completion Date: |
2024-03-22
|
| Results First Posted: |
2025-03-28
|
| Last Update Posted: |
2025-03-28
|
| Locations: |
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05266963
|
