Evaluation of OGTT in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization

Evaluation of Oral Glucose Tolerance Testing in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization: a Cross-sectional Trial

To evaluate the islet function and insulin secretion pattern of post-pancreatitis diabetes mellitus by oral glucose tolerance testing, and to explore the pathophysiological characteristics of PPDM-C which provide evidence for the diagnosis of PPDM-C.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Chronic Pancreatitis; Oral Glucose Tolerance Test; Pancreatogenic Type 3C Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: blood test; Device: Continuous Glucose Monitor

Detailed Description

Blood samples will be collected from patients with chronic pancreatitis by oral glucose tolerance test (steamed bun meal test, SBMT) to assess their pancreatic islet function and insulin secretion pattern, measure other intestinal hormones, exosomes, plasma metabolites, and serum biochemical factors to characterize the pathophysiological features of PPDM-C and provide evidence for the diagnosis of PPDM-C. In order to better understand the glycemic fluctuations in patients with chronic pancreatitis combined with diabetes and guide subsequent treatment, Continuous Glucose Monitoring would be used in patients with chronic pancreatitis who had new-onset diabetes or poor glycemic control.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Zhuan Liao; Phone Number: 13061921980; Email: liaozhuan@smmu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Department of Gastroenterology, Changhai Hospital
      • Contact: zhuan liao, MD; Phone Number: 86-21-31161004; Email: liaozhuan@smmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with chronic pancreatitis treated in the Department of Gastroenterology of Changhai Hospital

Description

Inclusion Criteria:

1. Age 15-85
2. patients with the diagnosis of chronic pancreatitis and diabetes mellitus (exclude type 1 diabetes).
3. participants with painless chronic pancreatitis were diagnosed with diabetes within 2 years of the diagnosis of chronic pancreatitis.
4. participants with painful chronic pancreatitis were diagnosed with diabetes after the first attack of chronic pancreatitis.
5. patients with chronic pancreatitis were previously diagnosed type 2 diabetes mellitus for more than 3 years.

Exclusion Criteria:

1. Participants with suspected malignant tumors of the pancreas or other sites of the body (including pancreatic cyst and Benign pancreatic tumor), or participants in the terminal stage of severe disease
2. Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreatojejunostomy, or Frey), and prior bariatric or gastrointestinal surgery.
3. Serious mental illness, lesion of the liver (alanine aminotransferase or aspartate aminotransferase > 3 times the upper reference limit) or kidney (eGFR<60 mL/min/1.73 m2), pregnancy, breastfeeding or planning pregnancy, or accompanied with active liver diseases such as hepatitis B or hepatic cirrhosis.
4. Diagnosed type 1 diabetes, or other metabolic diseases that affect blood glucose
5. Using high-dose insulin preparations, or drugs affecting glucose metabolism (oral steroids, thiazide diuretics, beta-blockers, beta-agonist, nicotinic acid, immunosuppressant agents, antiretroviral drugs, and antipsychotics)
6. Acute complications of diabetes (diabetic ketoacidosis, severe hypoglycemia), severe microvascular disease (proliferative diabetic retinopathy, known diabetic nephropathy or neuropathy requiring treatment), and macrovascular disease (uncontrolled arterial hypertension, uncontrolled coronary artery disease, congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation) within the 12 months prior to enrollment.
7. Hospitalization for acute pancreatitis within the 2 months prior to enrollment or currently suffering acute inflammation.
8. Have been enrolled or currently participating in other clinical trials within the 3 months prior to enrollment.
9. Patients who refused to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CP; patients with chronic pancreatitis but not combined with diabetes	Diagnostic test: blood test; Evaluation of islets function and insulin secretion pattern： Evaluating the venous plasma glucose, c-peptide, and insulin concentrations at 0h, 0.5h, 1h, 2h, and 3h after the SBMT in patients with chronic pancreatitis. Characterization of pathophysiological features： Measuring intestinal hormones, exosomes, serum metabolites, and serum biochemical factors
PPDM-C; patients with post-chronic pancreatitis diabetes mellitus	Diagnostic test: blood test; Evaluation of islets function and insulin secretion pattern： Evaluating the venous plasma glucose, c-peptide, and insulin concentrations at 0h, 0.5h, 1h, 2h, and 3h after the SBMT in patients with chronic pancreatitis. Characterization of pathophysiological features： Measuring intestinal hormones, exosomes, serum metabolites, and serum biochemical factors; Device: Continuous Glucose Monitor; blood glucose will be monitored 24 hours a day from 7 to 14 days by wearing continuous glucose monitor(only for patients who had new-onset diabetes or poor glycemic control )
CP+IGT; patients with chronic pancreatitis combined with impaired glucose tolerance	Diagnostic test: blood test; Evaluation of islets function and insulin secretion pattern： Evaluating the venous plasma glucose, c-peptide, and insulin concentrations at 0h, 0.5h, 1h, 2h, and 3h after the SBMT in patients with chronic pancreatitis. Characterization of pathophysiological features： Measuring intestinal hormones, exosomes, serum metabolites, and serum biochemical factors; Device: Continuous Glucose Monitor; blood glucose will be monitored 24 hours a day from 7 to 14 days by wearing continuous glucose monitor(only for patients who had new-onset diabetes or poor glycemic control )
CP+T2DM; patients with chronic pancreatitis combined with type 2 diabetes mellitus	Diagnostic test: blood test; Evaluation of islets function and insulin secretion pattern： Evaluating the venous plasma glucose, c-peptide, and insulin concentrations at 0h, 0.5h, 1h, 2h, and 3h after the SBMT in patients with chronic pancreatitis. Characterization of pathophysiological features： Measuring intestinal hormones, exosomes, serum metabolites, and serum biochemical factors; Device: Continuous Glucose Monitor; blood glucose will be monitored 24 hours a day from 7 to 14 days by wearing continuous glucose monitor(only for patients who had new-onset diabetes or poor glycemic control )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
steamed bun meal test result 1	Levels of glucose under the steamed bun meal experiment (100g flour made steamed bun)	Within 5 hours after the end of the steamed bread meal test
steamed bun meal test result 2	Levels of c-peptide bun meal experiment (100g flour made steamed bun)	Within 6 hours after the end of the steamed bread meal test
steamed bun meal test result 3	Levels of insulin under the steamed bun meal experiment (100g flour made steamed bun)	Within 7 hours after the end of the steamed bread meal test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gut hormone	Levels of gut hormone under the steamed bun meal experiment (100g flour made steamed bun)	up to 1 month
Continuous glucose monitor results	Time to target range (TIR) : the proportion of time with blood glucose fluctuation	after using continuous glucose monitor device for 7-14 days
glycemic control	glycosylated hemoglobin（%）	at the time of enrollment

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pancreatic Diseases; Chronic Disease; Diabetes Mellitus; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: ESTABLISH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No