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NCT Number: NCT01507597

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

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.

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Key information

Conditions

Type 2 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte University Hospital

Hellerup, DK-2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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)

NaCl

Drug

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)

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Food Intake

    Time frame: at 210 min

    Assessed by ad'libitum meal after the 210 min GLP-1 infusion / glucose clamp.

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2012
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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