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

NCT05989867 | Unknown

• 1 other identifier: ESTABLISH
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pancreatitis; Pancreatogenic Type 3C Diabetes Mellitus; Diabetes Mellitus; Oral Glucose Tolerance Test

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• gut hormone

  up to 1 month

• Continuous glucose monitor results

  after using continuous glucose monitor device for 7-14 days

• glycemic control

  at the time of enrollment

Study Arms (4)

CP

patients with chronic pancreatitis but not combined with diabetes

Diagnostic Test: blood test

PPDM-C

patients with post-chronic pancreatitis diabetes mellitus

Diagnostic Test: blood test; Device: Continuous Glucose Monitor

CP+IGT

patients with chronic pancreatitis combined with impaired glucose tolerance

Diagnostic Test: blood test; Device: Continuous Glucose Monitor

CP+T2DM

patients with chronic pancreatitis combined with type 2 diabetes mellitus

Diagnostic Test: blood test; Device: Continuous Glucose Monitor

Interventions

blood test DIAGNOSTIC_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

CP; CP+IGT; CP+T2DM; PPDM-C

Continuous Glucose Monitor DEVICE

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; CP+T2DM; PPDM-C

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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
• Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreatojejunostomy, or Frey), and prior bariatric or gastrointestinal surgery.
• 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.
• Diagnosed type 1 diabetes, or other metabolic diseases that affect blood glucose
• 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)
• 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.
• Hospitalization for acute pancreatitis within the 2 months prior to enrollment or currently suffering acute inflammation.
• Have been enrolled or currently participating in other clinical trials within the 3 months prior to enrollment.
• Patients who refused to participate in the study

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Department of Gastroenterology, Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic; Diabetes Mellitus

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Zhuan Liao

CONTACT

13061921980; liaozhuan@smmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 14, 2023
• Study Start: March 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-07

Locations

CN (1)