Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

NCT03030209 | Completed DMC

• 1 other identifier: PUMCH-GS03
• Study Type: observational
• Target: 485
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

pancreatectomy; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of participants with new-onset prediabetes as defined by American Diabetes Association

  Through study completion, an average of 3 year

• Number of participants with new-onset exocrine insufficiency

  Through study completion, an average of 3 year

Study Arms (1)

Distal Pancreatectomy

Patients undergoing distal pancreatectomy

Procedure: Distal pancreatectomy

Interventions

Distal pancreatectomy PROCEDURE

Distal pancreatectomy with or without splenectomy using minimal invasive or open approach

Distal Pancreatectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing distal pancreatectomy at our single tertiary referral hospital

You may qualify if:

• Patients undergoing distal pancreatectomy

You may not qualify if:

• Patients undergoing pancreaticoduodenectomy, middle pancreatectomy and enucleation
• Patients with preoperative DM
• Patients with functioning insulinoma and multiple endocrine neoplasia type 1

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

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

Beijing, 100730, China

Location

Related Publications (5)

• 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.

  PMID: 26390413 BACKGROUND

• 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.

  PMID: 23054900 BACKGROUND

• 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.

  PMID: 18543045 BACKGROUND

• 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.

  PMID: 22571457 BACKGROUND

• Dai M, Xing C, Shi N, Wang S, Wu G, Liao Q, Zhang T, Chen G, Wu W, Guo J, Liu Z. Risk factors for new-onset diabetes mellitus after distal pancreatectomy. BMJ Open Diabetes Res Care. 2020 Oct;8(2):e001778. doi: 10.1136/bmjdrc-2020-001778.

  PMID: 33122295 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2016
• First Posted: January 24, 2017
• Study Start: January 1, 2004
• Primary Completion: February 13, 2016
• Study Completion: February 13, 2016
• Last Updated: September 2, 2020

Record last verified: 2016-09

Locations

CN (1)