Effects of Pancreaticoduodenectomy on Glucose Metabolism

This study is currently recruiting participants.
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
  Purpose

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.


Condition
Diabetes Mellitus
Glucose Intolerance

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Pancreaticoduodenectomy on Glucose Metabolism

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Receiving pancreaticoduodenectomy

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving pancreaticoduodenectomy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388192

Contacts
Contact: Yu-Wen Tien, M.D., Ph.D. +886-0972651427 Ywtien5106@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yu-Wen Tien, Ph.D.    +886-972651427    kptkptkpt@yahoo.com.tw   
Principal Investigator: Yu-Wen Tien, Ph.D.         
Principal Investigator: Yu-wen Tien, Ph.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Yu-Wen Tien, M.D., Ph.D. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01388192     History of Changes
Other Study ID Numbers: 201104028RC
Study First Received: June 23, 2011
Last Updated: March 6, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Pancreaticoduodenectomy
diabetes
sugar metabolism

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on April 16, 2014