Clinical trial NCT05989867: Evaluation of OGTT in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization
Official title: Evaluation of Oral Glucose Tolerance Testing in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization: a Cross-sectional Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pancreatitis
Pancreatogenic Type 3C Diabetes Mellitus
Diabetes Mellitus
Oral Glucose Tolerance Test
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic pancreatitis treated in the Department of Gastroenterology of Changhai Hospital

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: steamed bun meal test result 1
timeFrame: Within 5 hours after the end of the steamed bread meal test
measure: steamed bun meal test result 2
timeFrame: Within 6 hours after the end of the steamed bread meal test
measure: steamed bun meal test result 3
timeFrame: Within 7 hours after the end of the steamed bread meal test
Secondary outcomes:
measure: gut hormone
timeFrame: up to 1 month
measure: Continuous glucose monitor results
timeFrame: after using continuous glucose monitor device for 7-14 days
measure: glycemic control
timeFrame: at the time of enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterology, Changhai Hospital
state: Shanghai
Study officials:
References: