Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

Early Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Placebo; Drug: CREON

• Registration Number: NCT05266963
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Study Start: 2022-09-02
• Primary Completion: 2024-03-22
• Study Completion: 2024-03-22
• Results First Submitted: 2025-02-27
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Results First Posted: 2025-03-28
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
CREON	CREON	CREON is a pancreatic enzyme replacement

Primary Outcome Measures

Name	Time	Method
Improvement in Glucose Regulation	through study completion (4-5 weeks)	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.
Patient-reported Change in Pancreatic Exocrine Insufficiency (PEI) Symptoms	through study completion (4-5 weeks)	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States