NCT05266963CompletedEarly phase 1
Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 14 Feb 2022
- Start date
- 2 Sept 2022
- Primary completion date
- 22 Mar 2024
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Type 1 diabetes
- NCT number
- NCT05266963
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 11
- From 2 Sept 2022 to the primary completion date, 22 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of celiac disease or inflammatory bowel disease
Lab values
- Use of medication or supplements other than insulin to control blood glucose
Other
- Pregnancy or breast feeding
- Following a restrictive diet (such as very low carb diet)
Who the study is looking for
- Currently receive care at the Eskind Diabetes Clinic at Vanderbilt University Medical Center
- Diagnosed with T1DM for at least 12 months
- Age over 18
- Total daily dose of insulin greater than 0.7u/kg/day
- Current use of a continuous glucose monitor
- Current use of smart phone
- Able to read and speak English
- Willingness and ability to download and provide CGM and pump (if applicable) data
- Reduction of pancreas volume (\<0.6mL/kg body weight)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.