Glucose Metabolism After Partial Pancreatectomy

Diabete Mellitus Clinical Trial

Official title:

Alteration of Glucose Metabolism After Partial Pancreatectomy Assessed With Biochemical Markers :A Single Center Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409171
• Other study ID #: SNUBH-GS-HBP6
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a single center observational study to assess alteration of glucose metabolism after pancreatectomy.

Description:

Biochemical markers of glucose metabolism including oral glucose tolerance tests, fasting blood glucose, insulin, glucagon and HbA1c were performed on patients receiving pancreatectomy (pancreaticoduodenectomy and distal pancreatectomy). Tests were done preoperatively, postoperatively at 3 months, and at 1 year. The primary endpoints were the incidence and risk factors of new-onset and worsened DM after each type of pancreatectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• partial pancreatectomy

Exclusion Criteria:

• total pancreatectomy

• incomplete testing

• follow-up loss

• death within 1 year

Related Conditions & MeSH terms

• Diabete Mellitus
• Diabetes Mellitus
• Hyperglycemia
• Pancreatectomy; Hyperglycemia

Intervention

Diagnostic Test:
• oral glucose tolerance test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

References & Publications (2)

Hwang HK, Park J, Choi SH, Kang CM, Lee WJ. Predicting new-onset diabetes after minimally invasive subtotal distal pancreatectomy in benign and borderline malignant lesions of the pancreas. Medicine (Baltimore). 2017 Dec;96(51):e9404. doi: 10.1097/MD.0000000000009404. — View Citation

Lee BW, Kang HW, Heo JS, Choi SH, Kim SY, Min YK, Chung JH, Lee MK, Lee MS, Kim KW. Insulin secretory defect plays a major role in the development of diabetes in patients with distal pancreatectomy. Metabolism. 2006 Jan;55(1):135-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence & risk factors of new-onset DM	incidence & risk factors of new onset DM after pancreatectomy	at 1 year
Primary	incidence & risk factors of worsened DM	incidence & risk factors of worsened DM after pancreatectomy	at 1 year
Secondary	characteristics of new-onset and worsened DM	changes of glucose metabolism during study period	1 year