Glucagon Modulation of Ghrelin Secretion
Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects; Obesity; Diabetes Mellitus, Type 1
Intervention: Glucagon hydrochloride (GlucaGen®) (Drug); NaCl 0.9% (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s): Ayman M Arafat, Dr.med., Principal Investigator, Affiliation: Charite Campus Benjamin Franklin
Summary
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.
Clinical Details
Official title: The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Primary outcome: Changes in satiety scale, total and acylated ghrelin concentrations.
Secondary outcome: Changes in glucose, insulin and NEFA concentrations.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Charite Campus Benjamin Franklin, Berlin 12200, Germany
Additional Information
Department website
Related publications: Arafat AM, Perschel FH, Otto B, Weickert MO, Rochlitz H, Schöfl C, Spranger J, Möhlig M, Pfeiffer AF. Glucagon suppression of ghrelin secretion is exerted at hypothalamus-pituitary level. J Clin Endocrinol Metab. 2006 Sep;91(9):3528-33. Epub 2006 Jun 20.
Starting date: June 2006
Last updated: June 29, 2009
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