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

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Type 1 Diabetes; Type 2 Diabetes

Treatments: Drug: NaCl; Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36))

Study type: Interventional

Funder types: Other

Identifiers

NCT01507597

GlukaStase

H-3-2011-088 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Healthy Subjects

Other group

Treatment:

Drug: NaCl

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

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

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

T2DM

Other group

Treatment:

Drug: NaCl

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

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

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

T1DM

Other group

Treatment:

Drug: NaCl

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

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

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