Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

Completed

• Conditions: Diabetes Mellitus
• Interventions: Procedure: Distal pancreatectomy

• Registration Number: NCT03030209
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-01-01
• Primary Completion: 2016-02-13
• Study Completion: 2016-02-13
• Status Verified: 2016-09
• Study First Submitted: 2016-09-17
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-24
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Distal Pancreatectomy	Distal pancreatectomy	Patients undergoing distal pancreatectomy

Primary Outcome Measures

Name	Time	Method
Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with new-onset exocrine insufficiency	Through study completion, an average of 3 year	Exocrine insufficiency is defined as patients requiring oral pancreatic enzyme replacement because of severe diarrhea.
Number of participants with new-onset prediabetes as defined by American Diabetes Association	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)

Trial Locations

Locations (1)

Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; 🇨🇳 Beijing, China