Effects of Pancreaticoduodenectomy on Glucose Metabolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01388192
First received: June 23, 2011
Last updated: March 6, 2014
Last verified: March 2014

June 23, 2011
March 6, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
Change of glucose metabolism after pancreaticoduodenectomy [ Time Frame: on the post-operative day 5 and day 6 ] [ Designated as safety issue: No ]
Measurement of glucose, glucagon-like peptide-1, Measurement of insulin, C-peptide, and glucagon concentrations after meal test
Change of glucose metabolism after pancreaticoduodenectomy [ Time Frame: on the morning of surgery (day 1), 6 days later, and again at 1 and 6 months after surgery. ] [ Designated as safety issue: No ]
response of 50 g oral glucose tolerance test, Measurement of glucagon-like peptide-1, Measurement of insulin, C-peptide, and glucagon concentrations
Complete list of historical versions of study NCT01388192 on ClinicalTrials.gov Archive Site
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Effects of Pancreaticoduodenectomy on Glucose Metabolism
Effects of Pancreaticoduodenectomy on Glucose Metabolism

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.

Questionaire All studied patients will be requested to self-complete a detailed questionnaire that collects information on demographic data, including usual adult height and weight, and history of DM in first-degree relatives. Existing medical conditions, including DM, duration of these medical problems, and current medications will also be inquired. The database will also include details of weight measured at the time of recruitment and body mass index (BMI), calculated as weight (kg)/height2 (m2). All studied patients will have FBG levels measured. Patients receiving prescription antidiabetic medications for previously diagnosed DM will be classified as having DM regardless of their FBG value. Among patients not reporting treatment for DM, classification of DM status will be based on the American Diabetes Association criteria; patients will be classified as having DM if the FBG level is ≧126 mg/dL (7 mmol/L), as having impaired fasting glucose (IFG) if their FBG is between 100 and 125 mg/dL (5.6-6.9 mmol/L), and as having normal fasting glucose (NFG) if their FBG value is ≦99 mg/dL (5.5 mmol/L).

After withdrawal of anti-diabetic medications for 12 h, the patients were asked to fast overnight for 12 h, then were given 200 ml of formula (220kcal, 14g of protein, 28 g of carbohydrates, and 5 g of fat; Modifast, Stocksund, Sweden) within 10 min through a NG tube on post-operative day 5 (proximal feeding group [PFG]) and a jejunostomy feeding tube (distal feeding group [DFG]) on post-operative day 6. The below parameter will be checked, including

  1. HOMA insulin resistance assessment (HOMA-IR)
  2. GLP-1
  3. GIP
  4. C-peptide
  5. Insulin
  6. Glucose
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients receiving pancreaticoduodenectomy

  • Diabetes Mellitus
  • Glucose Intolerance
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Receiving pancreaticoduodenectomy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients receiving pancreaticoduodenectomy

Exclusion Criteria:

  • history of pancreatitis
  • hepatic dysfunction (Child-Pugh > 2)
  • renal dysfunction (serum creatinine concentration > 3 mg/L, hemodialysis, or both)
  • pregnancy
Both
18 Years and older
No
Contact: Yu-Wen Tien, M.D., Ph.D. +886-0972651427 Ywtien5106@ntu.edu.tw
Taiwan
 
NCT01388192
201104028RC
Yes
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Study Chair: Yu-Wen Tien, M.D., Ph.D. National Taiwan University Hospital
National Taiwan University Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP