The Effect of GLP-1 on the Inhibition of Glucagon Secretion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Plasma GLP-1 response to the GLP-1 infusion / glucose clamp
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Healthy Subjects
Intervention: Native human Glucagon-like Peptide-1 ( GLP-1(7-36)) (Drug)
Healthy Subjects
Intervention: NaCl (Drug)
T2DM
Intervention: Native human Glucagon-like Peptide-1 ( GLP-1(7-36)) (Drug)
T2DM
Intervention: NaCl (Drug)
T1DM
Intervention: Native human Glucagon-like Peptide-1 ( GLP-1(7-36)) (Drug)
T1DM
Intervention: NaCl (Drug)
Outcomes
Primary Outcomes
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 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 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
- Resting Metabolic Rate response to the GLP-1 infusion / glucose clamp(at 0, 120, and 180 min)
- 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)
- 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)
- 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)
- Food Intake(at 210 min)
Investigators
Jonatan I Bagger
Principal Investigator
University Hospital, Gentofte, Copenhagen