Pancreatin Added to Standard Antihyperglycemic Therapy in Patients With Type 2 Diabetes
The Effect of Pancreatin Added to Standard Antihyperglycemic Therapy on Metabolic Control in Patients With Type 2 Diabetes
Medications that enhance the incretin effect (GLP-1 receptor agonists, tirzepatide (GIP/GLP-1 receptor agonist) and DPP-4 inhibitors) are used in treatment of patients with type 2 diabetes. GLP-1 agonists and tirzepatide not only effectively lower blood glucose levels but also promote weight loss-primarily by stimulating the satiety center in the central nervous system - and reduce cardiovascular risk. Evidence suggests that oral pancreatin supplementation also enhances the incretin effect by increasing GIP and GLP-1 concentrations, and consequently insulin levels, which translates into a reduction in postprandial glycemia in patients with cystic fibrosis or chronic pancreatitis. In our study we aim to evaluate the impact of pancreatin on the incretin effect and glycemic control in patients with type 2 diabetes without exocrine pancreatic insufficiency.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) are the two primary incretin hormones secreted from the small intestine on ingestion of glucose or nutrients to stimulate insulin secretion from pancreatic β cells. They play a role in regulation of blood glucose levels, particularly postprandial glycemia. Lipids and carbohydrates are the most potent stimulators of incretin hormone secretion. Pancreatin is a mixture of digestive enzymes naturally produced by the pancreas, which is used as a medication supporting macronutrient digestion, especially in cases of exocrine pancreatic insufficiency. Evidence suggests that oral pancreatin supplementation enhances the incretin effect by increasing GIP and GLP-1 concentrations, and consequently insulin levels, which translates into a reduction in postprandial glycemia in patients with cystic fibrosis or chronic pancreatitis. Based on a randomized, placebo-controlled, double-blind study, we aim to evaluate the effect of pancreatin on the incretin effect and glycemic control in patients with type 2 diabetes without exocrine pancreatic insufficiency.
We plan to recruit a total of 100 patients with type 2 diabetes treated with oral antihyperglycemic drugs or insulin, either as monotherapy or in combination. Patients will be randomly divided into 2 groups:
- Group of 50 patients receiving pancreatin 25 000 U with up to 3 main meals daily for 3 months
- Group of 50 patients receiving placebo with up to 3 main meals daily for 3 months
Baseline assessment:
- Anthropometric parameters: body weight, height, waist-to-hip ratio, body composition (bioelectrical impedance analysis)
- Laboratory tests: aspartate aminotransferase, alanine aminotransferase, serum amylase, lipid profile, HbA1c, selected cytokines, average glucose concentration from the last 7 days before study start (glucometer - 4 measurements per day), data from the FreeStyle Libre2 continuous glucose monitoring system (2 weeks prior to study start): assessment of TIR (Time in Range 70-180 mg/dL), glycemic variability coefficient (CV), standard deviation (SD), mean glucose concentration, frequency and severity of hypoglycemia; daily insulin requirements from the last 7 days (for insulin-treated patients)
Assessment after study completion:
- Anthropometric parameters: body weight, height, waist-to-hip ratio, body composition (bioelectrical impedance analysis)
- Laboratory tests: aspartate aminotransferase, alanine aminotransferase, serum amylase, lipid profile, HbA1c, selected cytokines, average glucose concentration from the last 7 days before study end (glucometer - 4 measurements per day), data from the FreeStyle Libre 2 continuous glucose monitoring system (last 2 weeks of study): assessment of TIR, CV, SD, mean glucose concentration, frequency and severity of hypoglycemia; daily insulin requirements from the last 7 days (for insulin-treated patients).
Should pancreatin demonstrate a beneficial effect on glycemic homeostasis, these formulations could serve as a valuable adjunctive therapy for type 2 diabetes.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Marta Wróbel, PhD
- Phone Number: 48606873060
- Email: mwrobel@sum.edu.pl
Study Contact Backup
- Name: Paulina Piekarz-Ząbek, MD
- Phone Number: +48 604 223 652
- Email: k_bielawa@poczta.fm
Study Locations
-
-
Silesian Voivodeship
-
Zabrze, Silesian Voivodeship, Poland, 41-800
- Recruiting
- Department of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze
-
Contact:
- Paulina Piekarz-Ząbek, MD
- Phone Number: +48 604 223 652
- Email: k_bielawa@poczta.fm
-
Contact:
- Marta Wróbel, PhD
- Phone Number: +48606873060
- Email: mwrobel@sum.edu.pl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetes diagnosed for at least 12 months
- Patients treated with oral antihyperglycemic agents and/or insulin as monotherapy or combination therapy
- Age between 35 and 75 years
- HbA1c: 6.5% - 9.0%
Exclusion Criteria:
- Type 1 diabetes
- Use of incretin-based drugs (GLP-1 receptor agonists, dual GIP and GLP-1 receptor agonists, DPP-4 inhibitors) currently or within the last 3 months
- History of pancreatic surgery
- History of chronic pancreatitis
- History of acute pancreatitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pancreatin
Participants receiving pancreatin |
Pancreatin 25 000 U with each of the 3 main meals daily for 3 months
Other Names:
|
|
Placebo Comparator: Control
Participants receiving placebo |
Placebo capsule with each of the 3 main meals daily for 3 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic control
Time Frame: 3 months
|
HbA1c value |
3 months
|
|
Time in range
Time Frame: 3 months
|
Time in range (glucose 70-180 mg/dl) |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight
Time Frame: 3 months
|
Body weight measurement |
3 months
|
|
Lipid profile
Time Frame: 3 months
|
Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglicerides |
3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marta Wróbel, PhD, Department of Internal Medicine, Diabetology and Cardiometabolic Disorders
Publications and helpful links
General Publications
- Perano SJ, Couper JJ, Horowitz M, Martin AJ, Kritas S, Sullivan T, Rayner CK. Pancreatic enzyme supplementation improves the incretin hormone response and attenuates postprandial glycemia in adolescents with cystic fibrosis: a randomized crossover trial. J Clin Endocrinol Metab. 2014 Jul;99(7):2486-93. doi: 10.1210/jc.2013-4417. Epub 2014 Mar 26.
- Knop FK, Vilsboll T, Larsen S, Hojberg PV, Volund A, Madsbad S, Holst JJ, Krarup T. Increased postprandial responses of GLP-1 and GIP in patients with chronic pancreatitis and steatorrhea following pancreatic enzyme substitution. Am J Physiol Endocrinol Metab. 2007 Jan;292(1):E324-30. doi: 10.1152/ajpendo.00059.2006. Epub 2006 Sep 5.
- Ebert R, Creutzfeldt W. Reversal of impaired GIP and insulin secretion in patients with pancreatogenic steatorrhea following enzyme substitution. Diabetologia. 1980 Sep;19(3):198-204. doi: 10.1007/BF00275269.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pancreatin - type 2 diabetes
- BNW-1-089/N/5/K (Other Grant/Funding Number: Medical University of Silesia, Katowice, Poland)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Deidentified individual participant data and the study protocol will be made available upon reasonable request.
IPD Sharing Time Frame
after publication, till 5 yrs
IPD Sharing Access Criteria
via email:mwrobel@sum.edu.pl
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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