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NCT04409171 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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