Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— CREON  

Official title:

Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05266963
• Other study ID #: 210734
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: September 2, 2022
• Est. completion date: February 2025

Study information

• Verified date: September 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• History of celiac disease or inflammatory bowel disease

• Use of medication or supplements other than insulin to control blood glucose

• Pregnancy or breast feeding

• Following a restrictive diet (such as very low carb diet)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• CREON
The study will enroll 6-10 adult subjects with T1D who will receive both pancreatic enzyme replacement (CREON) or placebo each for 7 days in a random order. The effect of the intervention will be monitored by continuous glucose monitoring, diet recording, capsule counts, a mixed-meal tolerance test, and a survey to assess symptoms of PEI. This study design will allow for estimation of the effect of pancreatic enzyme replacement on the measured parameters.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in glucose regulation	Mixed meal tolerance testing (MMTT) will be used to assess glucose regulation at baseline, and after treatment with placebo and creon in a random order.	through study completion (4-5 weeks)
Primary	Patient-reported change in pancreatic exocrine insufficiency (PEI) symptoms	We will use the PEI questionnaire to quantitate symptoms of PEI and their relative change at baseline and after treatment with placebo and creon in a random order.	through study completion (4-5 weeks)