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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507597
• Other study ID #: GlukaStase
• Secondary ID: H-3-2011-088
• Status: Completed
• Phase: N/A
• First received: December 13, 2011
• Last updated: December 9, 2013
• Start date: December 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

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)
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
Denmark	Gentofte University Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Glucagon response to the GLP-1 infusion / glucose clamp	The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session	At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min	No
Primary	Plasma GLP-1 response to the GLP-1 infusion / glucose clamp	The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session	At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min	No
Primary	Plasma Glucose response to the GLP-1 infusion / glucose clamp	The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session	At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min	No
Secondary	Resting Metabolic Rate response to the GLP-1 infusion / glucose clamp	Assessed by indirect calorimetry during the GLP-1 infusion / glucose clamp-session	at 0, 120, and 180 min	No
Secondary	Hunger scores response to the GLP-1 infusion / glucose clamp	Assessed by VAS during the 210 min GLP-1 infusion / glucose clamp-session	At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min	No
Secondary	plasma Insulin response to the GLP-1 infusion / glucose clamp	The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session	At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min	No
Secondary	plasma GIP response to the GLP-1 infusion / glucose clamp	The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session	At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min	No
Secondary	Food Intake	Assessed by ad'libitum meal after the 210 min GLP-1 infusion / glucose clamp.	at 210 min	No