Evaluating glucose tolerance in patients with diabetes after pancreatitis
Evaluation of Oral Glucose Tolerance Testing in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization: a Cross-sectional Trial
This study is testing how well people with diabetes after pancreatitis can handle sugar to better understand their condition and improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 15 Years to 85 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05989867 on ClinicalTrials.gov |
What this trial studies
This study evaluates the islet function and insulin secretion patterns in patients with post-pancreatitis diabetes mellitus (PPDM-C) using an oral glucose tolerance test. Blood samples will be collected to assess various factors, including pancreatic islet function, intestinal hormones, and plasma metabolites. The study aims to characterize the pathophysiological features of PPDM-C and provide evidence for its diagnosis. Continuous Glucose Monitoring will also be utilized to understand glycemic fluctuations in these patients and guide treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15-85 with chronic pancreatitis and diabetes mellitus, specifically those diagnosed with diabetes within two years of chronic pancreatitis onset.
Not a fit: Patients with type 1 diabetes, malignant tumors, or those who have undergone significant pancreatic or gastrointestinal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnosis and management of diabetes in patients with chronic pancreatitis.
How similar studies have performed: While similar studies have explored glucose tolerance in diabetes, this specific approach focusing on post-pancreatitis diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai
- Department of Gastroenterology, Changhai Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Zhuan Liao
- Email: liaozhuan@smmu.edu.cn
- Phone: 13061921980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.