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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Type 1 Diabetes
• Interventions: Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36)); Drug: NaCl

• Registration Number: NCT01507597
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-11
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	Native human Glucagon-like Peptide-1 ( GLP-1(7-36))	-
Healthy Subjects	NaCl	-
T2DM	Native human Glucagon-like Peptide-1 ( GLP-1(7-36))	-
T2DM	NaCl	-
T1DM	Native human Glucagon-like Peptide-1 ( GLP-1(7-36))	-
T1DM	NaCl	-

Primary Outcome Measures

Name	Time	Method
Plasma GLP-1 response to the GLP-1 infusion / glucose clamp	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 Glucagon response to the GLP-1 infusion / glucose clamp	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	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 Outcome Measures

Name	Time	Method
Resting Metabolic Rate response to the GLP-1 infusion / glucose clamp	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	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	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	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	at 210 min	Assessed by ad'libitum meal after the 210 min GLP-1 infusion / glucose clamp.

Trial Locations

Locations (1)

Gentofte University Hospital; 🇩🇰 Hellerup, Denmark