Glucagon Modulation of Ghrelin Secretion

Obesity Clinical Trial

Official title:

The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00929812
• Other study ID #: GluGhr-study 01082005
• Secondary ID: EudoraCT 2005-00
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 29, 2009
• Last updated: June 29, 2009
• Start date: June 2006
• Est. completion date: December 2009

Study information

• Verified date: June 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: December 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Healthy Subjects
• Obesity

Intervention

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

Locations

Country	Name	City	State
Germany	Charite Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in satiety scale, total and acylated ghrelin concentrations.		During 240 min after Glucagon/Placebo administration.	No
Secondary	Changes in glucose, insulin and NEFA concentrations.		During 240 min after Glucagon/Placebo administration.	No

External Links

•   Department website