Involvement of Extrapancreatic Factors on Gastrointestinal-mediated Glucose Disposal (Px-GIGD)

November 30, 2015 updated by: Asger Lund, University Hospital, Gentofte, Copenhagen
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.

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Diabetes Research Division, University Hospital Gentofte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients operated at/or cared for at the endocrinology out-patient-clinic, Rigshospitalet, University of Copenhagen, Copenhagen Denmark

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal-mediated glucose disposal (GIGD)
Time Frame: Calculated when the study days are all complete. approximately in 6month
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
plasma Glucagon
Time Frame: Glucagon will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.
Glucagon will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endogenous glucose production
Time Frame: 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.
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.
Incretin Hormones
Time Frame: 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.
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.
Satiety, hunger, appetite
Time Frame: Satiety, hunger and appetite will be measured at time points:0,30,60,90,120,150,180 min during each day.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University of Copenhagen
European Foundation for the Study of Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

December 4, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-1-2012-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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