Involvement of Extrapancreatic Factors on Gastrointestinal-mediated Glucose Disposal

Diabetes Clinical Trial

— Px-GIGD  

Official title:

Involvement of Extrapancreatic Factors on Gastrointestinal-mediated Glucose Disposal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006459
• Other study ID #: H-1-2012-123
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: November 30, 2015
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

We want to investigate the mechanisms of extrapancreatic effects on gastrointestinal-mediated glucose disposal. In order to do so we will perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions in total pancreatectomised patients and in healthy controls.

Description:

In the current project we wish to identify the possible contribution of extrapancreatic effects on gastrointestinal-mediated glucose disposal (GIGD). GIGD reflects the percentage of an individual's glucose disposal following oral glucose tolerance test (OGTT) which is caused by the oral route of glucose administration. In healthy subjects GIGD amounts to ~60%. GIGD describes not only the impact of the incretin effect (insulinotropic substances released upon intestinal stimulation) but includes all factors affecting glucose disposal differently during oral vs. iv administration of glucose (including neural reflexes, activation of afferent nerves in the intestinal mucosa, differences in glucagon secretion, hepatic glucose production and first-pass hepatic uptake of glucose, differences in portal and venous blood glucose concentrations and/or at the present unknown factors. It is likely that the incretin effect (pancreatic effect) constitutes a major contributor to GIGD, but so far it has been impossible to discriminate between pancreatic and extrapancreatic mechanisms underlying GIGD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Pancreatectomized patients

• Caucasians above 18 years of age who have undergone total pancreatectomy

• Normal haemoglobin

• Informed consent Healthy Subjects

• Normal fasting plasma glucose (FPG) and normal HbA1C (according to the World Health Organization (WHO) criteria)

• Normal haemoglobin

• Age above 18 years

• Informed consent

Exclusion Criteria:

• Pancreatectomized patients

• Inflammatory bowel disease

• Operation within the last 3 months

• Ongoing chemotherapy or chemotherapy within the last 3 months

• Ostomy

• Nephropathy (serum creatinine >150 µM and/or albuminuria)

• Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3×normal values)

• Pregnancy and/or breastfeeding

• Age above 80 years

• Any condition that the investigator feels would interfere with trial participation Healthy Subjects

• Diabetes mellitus (DM)

• Prediabetes (impaired glucose tolerance and/or impaired FPG)

• First degree relatives with DM

• Inflammatory bowel disease

• Intestinal resection and/or ostomy

• Nephropathy (serum creatinine >150 µM and/or albuminuria

• Liver disease (ALAT and/or serum ASAT >2×normal values)

• Pregnancy and/or breastfeeding

• Age above 80 years

• Any condition that the investigator feels would interfere with trial participation

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
Denmark	Diabetes Research Division, University Hospital Gentofte	Hellerup

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	European Foundation for the Study of Diabetes, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal-mediated glucose disposal (GIGD)	GIGD will be calculated based on the amounts of glucose utilised during the two glucose administrations forms, OGTT and IIGI (GIGD (%) = 100%×(glucoseOGTT-glucoseIIGI)/glucoseOGTT)	Calculated when the study days are all complete. approximately in 6month	No
Primary	plasma Glucagon		Glucagon will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.	No
Secondary	endogenous glucose production	calculated based on infusions of stable isotope marked glucose	Endogenous glucose production will be calculated based on blood samples at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.	No
Secondary	Incretin Hormones	GIP, GLP-1	incretin hormone levels will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.	No
Secondary	Satiety, hunger, appetite	Will be measured with visual analogue scales (VAS)	Satiety, hunger and appetite will be measured at time points:0,30,60,90,120,150,180 min during each day.	No