Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

Diabetes Mellitus Clinical Trial

Official title:

Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030209
• Other study ID #: PUMCH-GS03
• Status: Completed
• Start date: January 1, 2004
• Est. completion date: February 13, 2016

Study information

• Verified date: September 2016
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: February 13, 2016
• Est. primary completion date: February 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Procedure:
• Distal pancreatectomy
Distal pancreatectomy with or without splenectomy using minimal invasive or open approach

Locations

Country	Name	City	State
China	Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

King J, Kazanjian K, Matsumoto J, Reber HA, Yeh MW, Hines OJ, Eibl G. Distal pancreatectomy: incidence of postoperative diabetes. J Gastrointest Surg. 2008 Sep;12(9):1548-53. doi: 10.1007/s11605-008-0560-5. Epub 2008 Jun 10. — View Citation

Kwon JH, Kim SC, Shim IK, Song KB, Lee JH, Hwang DW, Park KM, Lee YJ. Factors Affecting the Development of Diabetes Mellitus After Pancreatic Resection. Pancreas. 2015 Nov;44(8):1296-303. doi: 10.1097/MPA.0000000000000404. — View Citation

Shirakawa S, Matsumoto I, Toyama H, Shinzeki M, Ajiki T, Fukumoto T, Ku Y. Pancreatic volumetric assessment as a predictor of new-onset diabetes following distal pancreatectomy. J Gastrointest Surg. 2012 Dec;16(12):2212-9. doi: 10.1007/s11605-012-2039-7. Epub 2012 Sep 28. — View Citation

You DD, Choi SH, Choi DW, Heo JS, Ho CY, Kim WS. Long-term effects of pancreaticoduodenectomy on glucose metabolism. ANZ J Surg. 2012 Jun;82(6):447-51. doi: 10.1111/j.1445-2197.2012.06080.x. Epub 2012 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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