ClinicalTrials.gov
ClinicalTrials.gov Menu

The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03181191
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Mille Baekdal Nielsen, University Hospital, Gentofte, Copenhagen

June 6, 2017
June 8, 2017
June 12, 2017
April 27, 2017
December 31, 2018   (Final data collection date for primary outcome measure)
gut-derived glucagon [ Time Frame: 1 year ]
The primary objective is to investigate mucosal biopsies from specific regions of the upper gastrointestinal tract
Same as current
Complete list of historical versions of study NCT03181191 on ClinicalTrials.gov Archive Site
Oral glucose tolerance test [ Time Frame: 45 minutes ]
Glucose metabolism - hormones, insulin, glucagon, glp-1
Same as current
Not Provided
Not Provided
 
The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion
The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion
Delineation of the anatomical location, cellular origin and molecular basis of gut-derived glucagon secretion

Aim: to delineate the anatomical origin, the molecular structure and precursors, the regulation and the (patho-) physiological implications of gut-derived glucagon.

Eight totally pancreatectomised patients, eight type 2 diabetes patients and eight healthy controls (age 18-80, BMI <30) with normal kidney and liver parameters and hgb> 6.5 - will be included. The participants will each undergo one screening day and one study day including a gastroduodenoscopy. Multiple biopsies will be taken at several predefined locations in the upper gastrointestinal tract. These biopsies will be analysed with different techniques including immunohistochemical staining, quantitative polymerase chain reaction (qPCR-) analyses and more to search for glucagon. After the last biopsy has been collected, 50 g of glucose dissolved in 100 ml water is infused through the enteroscope into the most proximal part of the small intestine. Hereafter blood samples for glucagon and gut hormone analyses will be collected 15, 30 and 45 min after the glucose infusion.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Glucose Metabolism Disorders
Other: Oral glucose tolerance test
Oral glucose tolerance test and biopsies
  • Active Comparator: Totally pancreatectomised patients
    Oral glucose tolerance test and biopsies
    Intervention: Other: Oral glucose tolerance test
  • Active Comparator: Type 2 diabetes patients
    Oral glucose tolerance test and biopsies
    Intervention: Other: Oral glucose tolerance test
  • Active Comparator: Healthy control subjects
    Oral glucose tolerance test and biopsies
    Intervention: Other: Oral glucose tolerance test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • normal kidney function, normal liver function, normal hemoglobin levels

Exclusion Criteria:

  • diabetes type 1, first degree relatives with type 2 diabetes
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Yes
Contact: Mille Baekdal, MD +45 26700782 mille.baekdal.nielsen@regionh.dk
Contact: Filip Knop, MD, PhD filipknop@dadlnet.dk
Denmark
 
 
NCT03181191
UHG-CFD-PX-BIOPSY
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Mille Baekdal Nielsen, University Hospital, Gentofte, Copenhagen
Mille Baekdal Nielsen
University of Copenhagen
Study Director: Filip Knop, MD, PhD University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP