- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01388192
Effects of Pancreaticoduodenectomy on Glucose Metabolism
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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
- HOMA insulin resistance assessment (HOMA-IR)
- GLP-1
- GIP
- C-peptide
- Insulin
- Glucose
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
-
Kontakt:
- Yu-Wen Tien, Ph.D.
- Telefonnummer: +886-972651427
- E-mail: kptkptkpt@yahoo.com.tw
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Ledende efterforsker:
- Yu-Wen Tien, Ph.D.
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Receiving pancreaticoduodenectomy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change of glucose metabolism after pancreaticoduodenectomy
Tidsramme: on the post-operative day 5 and day 6
|
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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Yu-Wen Tien, M.D., Ph.D., National Taiwan University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201104028RC
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