Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

Study Overview
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Brief Summary
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Glucose homeostasis changes after distal pancreatectomy are not well understood. This study aim to identify the incidence of and risk factors for, a change in glucose homeostasis in patients who underwent distal pancreatic resection.

Detailed Description
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The development of sophisticated surgical procedures, improved postoperative care, and the capacity for early diagnosis of disease, have prolonged life expectancy after pancreatic resection. For these patients, the endocrine function of the pancreas is a critical factor that influences quality of life. In this study, the investigators recruit patients who underwent distal pancreatectomy in Peking Union Medical College Hospital within the last 10 years. Demographic characteristics, operative parameters and short-term postoperative outcomes were collected in a prospective database maintained by the Pancreatic Surgical Centre, Peking Union Medical College Hospital. These patients are followed up regularly by outpatient visiting or telephone for long-term outcomes. The primary outcome of this study is new-onset diabetes mellitus; second outcomes include impaired fasting glucose, impaired glucose tolerance, exocrine insufficiency and disease recurrence. This study aim to determine the cumulative rates of endocrine insufficiency, and identify risk factors for DM development in a large cohort of patients undergoing distal pancreatectomy.

Official Title
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Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Procedure: Distal pancreatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing distal pancreatectomy Exclusion Criteria: Patients undergoing pancreaticoduodenectomy, middle pancreatectomy and enucleation Patients with preoperative DM Patients with functioning insulinoma and multiple endocrine neoplasia type 1
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Distal Pancreatectomy<br>Patients undergoing distal pancreatectomy | Procedure: Distal pancreatectomy<br>* Distal pancreatectomy with or without splenectomy using minimal invasive or open approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association | The criteria for the diagnosis of diabetes developed by American Diabetes Association (1) FPG (fasting plasma glucose) ≥ 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.* OR (2) 2-h PG (plasma glucose) ≥ 200 mg/dL (11.1mmol/L) during an OGTT (oral glucose tolerance test). The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.* OR (3) A1C ≥ 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.* (lower-upper limit: 4.5%-6.3% in PUMCH) OR (4) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L). *In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing. | Through study completion, an average of 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with new-onset prediabetes as defined by American Diabetes Association | The categories of prediabetes (increased risk for diabetes) (1) Impaired fasting glucose (IFG): FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L). (3.6 - 6.1 mmol/L in PUMCH) OR (2) Impaired glucose tolerance (IGT): 2-h PG in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L). The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. OR (3) A1C 5.7-6.4% (39-46 mmol/mol) | Through study completion, an average of 3 year | 
| Number of participants with new-onset exocrine insufficiency | Exocrine insufficiency is defined as patients requiring oral pancreatic enzyme replacement because of severe diarrhea. | Through study completion, an average of 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatectomy, diabetes mellitus