Glucagon Modulation of Ghrelin Secretion

Official Title: “The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion”

As a counterregulatory hormone for insulin, glucagon plays a critical role in maintaining glucose homeostasis in vivo. It is well known that intramuscular glucagon administration stimulates growth hormone (GH), adrenocorticotropic hormone (ACTH) and cortisol release in humans. Recently, it has been shown that glucagon induces a remarkable decrease in ghrelin levels. The mechanisms underlying this effect are unclear and the role of changes in glucose, insulin, glucagon-like peptide-1 (GLP-1) and catecholamines are widely discussed.

The aim of the present study is to further evaluate the effect of glucagon on ghrelin secretion and the possible role of the above mentioned factors in mediating this effect.

Intervention(s) in this Clinical Trial

• Drug: Glucagon hydrochloride (GlucaGen®)
  • 1 mg/1 ml of glucagon hydrochloride intramuscularly
• Drug: NaCl 0.9%
  • 1 ml NaCl 0.9% intramuscularly

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Glucagon hydrochloride
  • GlucaGen® 1 mg/1 ml intramuscularly
• Placebo Comparator: Placebo
  • 1 ml NaCl 0.9%

Primary Measures

• Changes in satiety scale, total and acylated ghrelin concentrations.
  • Time Frame: During 240 min after Glucagon/Placebo administration.
    Safety Issue?: No

Secondary Measures

• Changes in glucose, insulin and NEFA concentrations.
  • Time Frame: During 240 min after Glucagon/Placebo administration.
    Safety Issue?: No

Inclusion Criteria:

• Subjects > 18 and < 60 years old.
• Patients with diabetes type 1 should fulfill the following criteria:
• ICT Insulin therapy was necessary within the first 3 months after diagnosis;
• HbA1c-Wert < 7%.

Exclusion Criteria:

• Diabetes type 1 or 2 (for the healthy group).
• Biochemical evidence of impaired hepatic or renal function.
• History of cardiovascular disease.
• Uncontrolled hypertension.
• Current inflammatory, malignant or psychiatric disease.
• Pregnancy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Charite University, Berlin, Germany Other

Overall Clinical Trial Officials and Contacts

Ayman M Arafat, Dr.med. Principal Investigator Charite Campus Benjamin Franklin  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00929812

Study ID Number: GluGhr-study 01082005

ClinicalTrials.gov Identifier: NCT00929812

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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