An observational study in Chronic Pancreatitis, Pancreatogenic Type 3C Diabetes Mellitus and Diabetes Mellitus, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 15 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Changhai Hospital · Observational
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.
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.
752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's planned enrollment of 200 is above the median of 180 across 277 observational studies indexed under Pancreatitis.
Browse Pancreatitis studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
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Patients with chronic pancreatitis treated in the Department of Gastroenterology of Changhai Hospital
Exclusion Criteria:
patients with chronic pancreatitis but not combined with diabetes
Diagnostic Test: blood test
patients with post-chronic pancreatitis diabetes mellitus
Diagnostic Test: blood test · Device: Continuous Glucose Monitor
patients with chronic pancreatitis combined with impaired glucose tolerance
Diagnostic Test: blood test · Device: Continuous Glucose Monitor
patients with chronic pancreatitis combined with type 2 diabetes mellitus
Diagnostic Test: blood test · Device: Continuous Glucose Monitor
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
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 )
steamed bun meal test result 1
Levels of glucose under the steamed bun meal experiment (100g flour made steamed bun)
Time frame: 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)
Time frame: 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)
Time frame: Within 7 hours after the end of the steamed bread meal test
gut hormone
Levels of gut hormone under the steamed bun meal experiment (100g flour made steamed bun)
Time frame: up to 1 month
Continuous glucose monitor results
Time to target range (TIR) : the proportion of time with blood glucose fluctuation
Time frame: after using continuous glucose monitor device for 7-14 days
glycemic control
glycosylated hemoglobin（%）
Time frame: at the time of enrollment
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