Effects of Pancreaticoduodenectomy on Glucose Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

NCT03030209

Diabetes Mellitus

COMPLETED

The Comparison of Quality of Life in Patients With Pancreatogenic Diabetes After Pancreatectomy

NCT02985502

Quality of Life Diabetes Mellitus Pancreatectomy

UNKNOWN

Pancreatic Islet Function, Insulin Sensitivity, and Chronic Complications in Pre-Diabetes

NCT00172796

Prediabetic State Obesity Metabolic Syndrome X

UNKNOWN

Asian Diabetes Surgery Study (ADSS): Clinical Predictor for the Success of Metabolic Surgery

NCT01317979

Disease Endocrine System Disease Diabetes Mellitus

UNKNOWN

The Characteristics of Blood Glucose Profile and the Changes of Hormones in PPDM-C Population

NCT06826729

Chronic Pancreatitis Diabetes

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Glucose Intolerance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Receiving pancreaticoduodenectomy

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No