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CompletedNCT00497133Updated Jun 4, 2008

Alpha-Cell Sensitivity to GLP-1 in Patients With Type 2 Diabetes

An observational study in Type 2 Diabetes Mellitus, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-04.

Sponsored by University of Copenhagen · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
40 Years to 75 Years
Sex
All
01

Study summary

Glucagon-like peptide 1 is known to improve sensitivity of the pancreatic beta-cell. Further it inhibit secretion from the pancreatic alpha-cell by mechanisms not fully understand. With this study we wish to elucidate the potential of GLP-1 to increase the sensitivity of the alpha-cell.

Type 2 diabetic patients and control subjects receive infusions of GLP-1 in increasing doses or saline, alpha- and beta-cell responses are measured in blood-samples. During the study plasma-glucose levels are clamped at fasting levels.

With this study we hope to elucidate the pathophysiology behind defect glucose tolerance in type 2 diabetes mellitus and further more the potential of GLP-1 in treatment of type 2 diabetes mellitus.

Read the detailed description

Background: Glucagon-like peptide-1 (GLP-1) possesses insulinotropic and glucagonostatic properties, and, therefore, GLP-based antidiabetic therapies have been developed. Even though the insulinotropic potency of GLP-1 has been shown to be reduced in patients with type 2 diabetes mellitus (T2DM), a small dose of GLP-1 is capable of normalizing the beta-cell responsiveness to glucose in these patients. The glucagonostatic potency of GLP-1 in patients with T2DM is not known, and, furthermore, the capability of GLP-1 to reestablish normal glucagon secretion in these patients remains to be elucidated.

Objective: To investigate the alpha-cell sensitivity to GLP-1 in patients with T2DM and to establish if GLP-1 is able to reestablish normal glucagon secretion in such patients.

Method: Ten patients with T2DM and ten healthy control subjects are clamped at their fasting blood glucose levels during GLP-1 infusions at increasing doses (0.25, 0.5, 1.0 and 2.0 pmol/kg/min) and placebo, respectively. Furthermore, the patients will be hospitalized overnight while receiving intravenous insulin and thereafter examined under normoglycaemic conditions. Blood are being drawn for analysis of plasma insulin, C-peptide, GLP-1 and glucagon.

Expected results and conclusions: We expect that GLP-1 will inhibit glucagon secretion in a dose dependent manner, leading too an increase in glucose turn-over. The results will potentially elucidate the interaction between GLP-1 and glucagon secretion and thereby broaden our knowledge on the pathophysiology of T2DM. Furthermore, the present study will determine the therapeutic impact of GLP-1 on the alpha-cell deficiency characterizing patients with T2DM.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • glucoseintolerance
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 planned 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 of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

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

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Study population

Patients with type 2 diabetes mellitus and matched control subjects.

Inclusion criteria

  • Informed oral and written consent
  • Caucasians aged > 18 years diagnosed with T2DM due to WHO criteria.
  • Normal haemoglobin
  • HbA1c 6-10%
  • BMI 23-35 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Hepatic disease, ALAT > 2 x normal.
  • Diabetic nephropathy, (S-creatinine >130μM or albuminuria).
  • Diabetic neuropathy (reported)
  • Proliferative diabetic retinopathy (reported)
  • Medical treatment that cannot be paused for 12 hours
  • Insulin- or glitazon treatment
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (estimated)
Biospecimen retention
Samples with dna
06

Study locations

1 site
  • Gentofte Hostital, Dep. og Internal Medicin F
    Gentofte, Hellerup DK-2900, Denmark
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00497133
Lead sponsor
University of Copenhagen
Collaborators
Novo Nordisk A/S, The Danish Diabetes Association
First posted
Jul 6, 2007
Start date
Jul 2007
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Jun 4, 2008

Study contacts

Jens Juul Holst, Professor, MD,MMSc
study director · University of Copenhagen, Department of Biomedical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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