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The Effect of GLP-1 on the Inhibition of Glucagon Secretion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507597
First Posted: January 11, 2012
Last Update Posted: December 10, 2013
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
December 13, 2011
January 11, 2012
December 10, 2013
December 2011
August 2013   (Final data collection date for primary outcome measure)
  • Plasma Glucagon response to the GLP-1 infusion / glucose clamp [ Time Frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min ]
    The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
  • Plasma GLP-1 response to the GLP-1 infusion / glucose clamp [ Time Frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min ]
    The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
  • Plasma Glucose response to the GLP-1 infusion / glucose clamp [ Time Frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min ]
    The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
Same as current
Complete list of historical versions of study NCT01507597 on ClinicalTrials.gov Archive Site
  • Resting Metabolic Rate response to the GLP-1 infusion / glucose clamp [ Time Frame: at 0, 120, and 180 min ]
    Assessed by indirect calorimetry during the GLP-1 infusion / glucose clamp-session
  • Hunger scores response to the GLP-1 infusion / glucose clamp [ Time Frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min ]
    Assessed by VAS during the 210 min GLP-1 infusion / glucose clamp-session
  • plasma Insulin response to the GLP-1 infusion / glucose clamp [ Time Frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min ]
    The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
  • plasma GIP response to the GLP-1 infusion / glucose clamp [ Time Frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min ]
    The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
  • Food Intake [ Time Frame: at 210 min ]
    Assessed by ad'libitum meal after the 210 min GLP-1 infusion / glucose clamp.
Same as current
Not Provided
Not Provided
 
The Effect of GLP-1 on the Inhibition of Glucagon Secretion
Not Provided

Diabetes(both types) are recognized by high levels of glucagon in the circulation.

Glucagon is known to increase blood glucose, and might therefore contribute to the respective diseases. Under some circumstances the gut hormone GLP-1 inhibits the glucagon secretion.

The investigators aim to identify the impact of GLP-1 on the glucagon secretion, at increasing blood glucose levels in healthy subjects, in patients with type 2 diabetes, and in patients with type 1 diabetes.

The investigators think that the effect of GLP-1 on the glucagon secretion might be dependent of blood glucose levels.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
  • Type 2 Diabetes
  • Type 1 Diabetes
  • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))

    Continuous iv. infusion of the native gut hormone GLP-1 (0.2 pmol/kg/min) for 210 minutes.

    Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)

  • Drug: NaCl
    Continuous iv. saline infusion (NaCl Isotonic) for 210 minutes. Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)
  • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))

    Continuous iv. infusion of the native gut hormone GLP-1 (0.4 pmol/kg/min) for 210 minutes.

    Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)

  • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))

    Continuous iv. infusion of the native gut hormone GLP-1 (0.8 pmol/kg/min) for 210 minutes.

    Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)

  • Healthy Subjects
    Interventions:
    • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))
    • Drug: NaCl
    • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))
    • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))
  • T2DM
    Interventions:
    • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))
    • Drug: NaCl
    • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))
    • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))
  • T1DM
    Interventions:
    • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))
    • Drug: NaCl
    • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))
    • Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with T2DM

  • Above the age of 35 years, treatment with diet or oral anti-diabetic medication. Diagnosed with T2DM in at leat three months in advance(WHO criterion)
  • Normal hemoglobin
  • Informed content Patients with T1DM
  • T1DM (WHO criterion)
  • Plasma-C-peptid negative due to arginin-test
  • Normal hemoglobin
  • age> 18 years
  • Informed content Healthy subjects
  • Normal fasting plasma glucose and normal glucose tolerance (WHO criterion)
  • Normal hemoglobin
  • Age >18 years
  • Informed content

Exclusion Criteria:

Patients with T2DM

  • Treatment with glitazones and/or gliptins
  • Inflammatory bowels disease
  • previous bowel resection with or without stomy
  • Nephropathy (serum creatinin >150 µM and/or albuminuria)
  • Liver disease (serum alanine-aminotransferase (ALAT) and/or serum aspartate-aminotransferase (ASAT) >2×normal values)
  • Medical treatment impossible to break for 12h.
  • Age >80 years Patients with T1DM
  • Overweight (BMI >30 kg/m2)
  • Inflammatory bowels disease
  • previous bowel resection with or without stomy
  • Nephropathy (serum creatinin >150 µM and/or albuminuria)
  • Liver disease (serum alanine-aminotransferase (ALAT) and/or serum aspartate-aminotransferase (ASAT) >2×normal values)
  • Medical treatment impossible to break for 12h (except treatment with insulin).
  • Age >80 years

Healthy subjects

  • Diabetes
  • Prediabetes (impaired glucose tolerance and/or impaired fasting plasma glucose)
  • First order relatives with diabetes
  • Overweight (BMI >30 kg/m2)
  • Inflammatory bowels disease
  • previous bowel resection with or without stomy
  • Nephropathy (serum creatinin >150 µM and/or albuminuria)
  • Liver disease (serum alanine-aminotransferase (ALAT) and/or serum aspartate-aminotransferase (ASAT) >2×normal values)
  • Medical treatment impossible to break for 12h.
  • Age >80 years
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01507597
GlukaStase
H-3-2011-088 ( Other Identifier: The Danish National Committee for Research Ethics )
No
Not Provided
Not Provided
Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen
Not Provided
Not Provided
University Hospital, Gentofte, Copenhagen
December 2013

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