Clinical trial NCT01507597: The Effect of GLP-1 on the Inhibition of Glucagon Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Type 1 Diabetes
Keywords: Glucagon-like peptide-1
Glucagon
Normal physiology
T2DM
T1DM
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma Glucagon response to the GLP-1 infusion / glucose clamp
timeFrame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
measure: Plasma GLP-1 response to the GLP-1 infusion / glucose clamp
timeFrame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
measure: Plasma Glucose response to the GLP-1 infusion / glucose clamp
timeFrame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
Secondary outcomes:
measure: Resting Metabolic Rate response to the GLP-1 infusion / glucose clamp
timeFrame: at 0, 120, and 180 min
measure: Hunger scores response to the GLP-1 infusion / glucose clamp
timeFrame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
measure: plasma Insulin response to the GLP-1 infusion / glucose clamp
timeFrame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
measure: plasma GIP response to the GLP-1 infusion / glucose clamp
timeFrame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
measure: Food Intake
timeFrame: at 210 min
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
Study officials:
References:
citation: Bagger JI, Grondahl MFG, Lund A, Holst JJ, Vilsboll T, Knop FK. Glucagonostatic Potency of GLP-1 in Patients With Type 2 Diabetes, Patients With Type 1 Diabetes, and Healthy Control Subjects. Diabetes. 2021 Jun;70(6):1347-1356. doi: 10.2337/db20-0998. Epub 2021 Mar 15.