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NCT05266963 · ClinicalTrials.gov registry record · Early Phase 1
Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes
A Early Phase 1 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT05266963 is a Early Phase 1 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 11 participants.
The verdict
NCT05266963, a Early Phase 1 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas. To date there has not been an investigation of the potential for pancreatic enzyme replacement therapy in the management of T1D. In individuals with cystic fibrosis-related diabetes, enzyme replacement has been shown to reduce post-prandial glycemia excursions, which are reflected in improved GLP-1 responses to mixed meal tolerance testing. As post-prandial excursions and glucose variability are a significant challenge in T1D, how enzyme replacement may impact these parameters is an important question. The investigators hypothesize that patients with T1DM who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic exocrine insufficiency when treated with pancreatic enzyme replacement (CREON).
Interventions
- DRUG Placebo
- DRUG CREON
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2022-09-02 |
| Est. Completion | 2024-03-22 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05266963
The ClinicalTrials.gov registry entry for NCT05266963 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05266963 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05266963 about?
NCT05266963 is a clinical study titled "Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes". Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, cha...
What is the current status of trial NCT05266963?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2022-09-02. Estimated completion is 2024-03-22.
What interventions are being tested in trial NCT05266963?
The interventions under investigation include: Placebo (DRUG), CREON (DRUG).
Who is sponsoring clinical trial NCT05266963?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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