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CompletedNCT00639613T2DM-PC1-2Updated Jun 26, 2015

The Role of Small Intestinal Endocrine Cells in Type 2 Diabetic Hyperglucagonemia

An observational study in Type 2 Diabetes, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-26.

Sponsored by University Hospital, Gentofte, Copenhagen · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
35 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether excessive secretion of glucagon in type 2 diabetes originates from the pancreatic alpha-cells or endocrine cells in the mucosa of the small intestinal.

Read the detailed description

Hyperglucagonemia contributes significantly to the hyperglycemia characterizing patients with Type 2 diabetes. Fasting hyperglucagonemia induces hepatic glucose release resulting in elevated fasting levels of plasma glucose. Furthermore, lack of postprandial suppression of glucagon secretion - exchanged for a paradoxical postprandial hypersecretion of glucagon - results in increased levels of postprandial plasma glucose. Additionally, type 2 diabetes is characterized by decreased postprandial responses of the insulinotropic (and glucagonostatic) peptide hormone glucagon-like peptide-1 (GLP-1). Recent studies from our group suggest that the intestines are involved in the diminshed suppression of glucagon following ingestion of nutrients. Thus, suppression of glucagon during oral glucose ingestion diminishes and reverses to stimulation while suppression during intravenous administered glucose sustains along with development of glucose intolerance. In the small intestines mucosal endocrine L-cells secrete GLP-1, which is processed from its precursor, proglucagon, by prohormone convertase 1 (PC1). In the pancreatic alpha-cells proglucagon is processed to glucagon via prohormone convertase 2 (PC2). We plan to examine biopsies from the mucosa of the small intestines from patients with type 2 diabetes and from healthy subjects for glucagon production. Furthermore, the volunteers will be subjected to a standard meal test in order to correlate the gene expression studies with the level of postprandial hyperglucagonemia of the subjects.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 20 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with type 2 diabetes

Inclusion criteria

  • Diagnosed with type 2 diabetes for at least 3 months
  • Normal hemoglobin
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Liver disease (ALAT/ASAT > 2 x normal range)
  • Diabetic nephropathy (se-creatinin > 130 µM and/or albuminuriu)
  • Treatment with medication that can not be stopped for12 hours
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Patients with type 2 diabetes

    Procedure: Double-balloon enteroscopy · Other: Standard meal test

  • 2

    Healthy subjects

    Procedure: Double-balloon enteroscopy · Other: Standard meal test

Interventions

  • ProcedureDouble-balloon enteroscopy

    Double-balloon enteroscopy allows for the entire gastrointestinal tract to be visualized in real time. The technique involves the use of a balloon at the end of a special enteroscope camera and an overtube, which is also fitted with a balloon. The procedure is usually done with the use of conscious sedation. The enteroscope and overtube are inserted through the mouth and passed in conventional fashion (that is, as with gastroscopy) into the small bowel. Following this, the endoscope is advanced a small distance in front of the overtube and the balloon at the end is inflated. Using the assistance of friction at the interface of the enteroscope and intestinal wall, the small bowel is accordioned back to the overtube. The overtube balloon is then deployed, and the enteroscope balloon is deflated. The process is then continued until the entire small bowel is visualized. Double-balloon enteroscopy allows for the sampling or biopsying of small bowel mucosa.

  • OtherStandard meal test

    Liquid meal consisting of 100 g "Ny NAN" dissolved in 300 ml water (ca. 5000 kJ) to be ingested over 5 minutes. Blood will be sampled for 4 hours following ingestion. Samples are centrifuges and plasma will be analysed for glucagon, GLP-1, GIP, insulin and C-peptide concentrations.

06

Study locations

1 site
  • Department of Internal Medicine F' laboratory
    Hellerup, Copenhagen County 2900, Denmark
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00639613
Lead sponsor
University Hospital, Gentofte, Copenhagen
Responsible party
Filip Krag Knop (Head of Diabetes Research Division, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Mar 20, 2008
Start date
Mar 2008
Primary completion
Jun 2015
Last update
Jun 26, 2015

Study contacts

Filip K Knop, MD PhD
principal investigator · Department of Internal Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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