Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy
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|ClinicalTrials.gov Identifier: NCT03030209|
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Procedure: Distal pancreatectomy|
|Study Type :||Observational|
|Actual Enrollment :||485 participants|
|Official Title:||Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy|
|Actual Study Start Date :||January 1, 2004|
|Actual Primary Completion Date :||February 13, 2016|
|Actual Study Completion Date :||February 13, 2016|
Patients undergoing distal pancreatectomy
Procedure: Distal pancreatectomy
Distal pancreatectomy with or without splenectomy using minimal invasive or open approach
- Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association [ Time Frame: Through study completion, an average of 3 year ]
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.
- Number of participants with new-onset prediabetes as defined by American Diabetes Association [ Time Frame: Through study completion, an average of 3 year ]
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)
- Number of participants with new-onset exocrine insufficiency [ Time Frame: Through study completion, an average of 3 year ]Exocrine insufficiency is defined as patients requiring oral pancreatic enzyme replacement because of severe diarrhea.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030209
|Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China|
|Beijing, China, 100730|
|Study Chair:||Menghua Dai, M.D.||Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China|