Effects of Pancreaticoduodenectomy on Glucose Metabolism
1 other identifier
observational
100
1 country
1
Brief Summary
Pancreaticoduodenectomy (PD) involves removing the head of pancreas, duodenum, common bile duct, gall bladder, and/or distal stomach. In general, the postoperative changes are thought to be moderately severe, and about 20% of these patients go on to develop new clinical diabetes. PD-related factors of glucose metabolism will include removal of half of the pancreatic endocrine tissue, exclusion of the proximal small intestine, postoperative weight loss (on average, \~8% of body weight), and removal of putative diabetogenic factor in resected neoplasm. However, effect of removal of duodenum on glucose metabolism after PD has never been studied. The investigators plan to examine this issue by comparing fasting plasma levels of insulin, fasting plasma glucose, C-peptide, HbA1C, HOMA-insulin resistance, GLP-1 response after a standard meal, and body mass index (BMI) of patients before and after PD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
July 6, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 26, 2016
January 1, 2016
5.1 years
June 23, 2011
January 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of glucose metabolism after pancreaticoduodenectomy
Measurement of glucose, glucagon-like peptide-1, Measurement of insulin, C-peptide, and glucagon concentrations after meal test
on the post-operative day 5 and day 6
Study Arms (1)
Receiving pancreaticoduodenectomy
Eligibility Criteria
Patients receiving pancreaticoduodenectomy
You may qualify if:
- Patients receiving pancreaticoduodenectomy
You may not qualify if:
- history of pancreatitis
- hepatic dysfunction (Child-Pugh \> 2)
- renal dysfunction (serum creatinine concentration \> 3 mg/L, hemodialysis, or both)
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yu-Wen Tien, M.D., Ph.D.
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
July 6, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 26, 2016
Record last verified: 2016-01