Glucagon Modulation of Ghrelin Secretion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00929812
Recruitment Status : Unknown
Verified June 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : June 30, 2009
Last Update Posted : June 30, 2009
Information provided by:
Charite University, Berlin, Germany

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Obesity Diabetes Mellitus, Type 1 Drug: Glucagon hydrochloride (GlucaGen®) Drug: NaCl 0.9% Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion
Study Start Date : June 2006
Actual Primary Completion Date : January 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Glucagon hydrochloride
GlucaGen® 1 mg/1 ml intramuscularly
Drug: Glucagon hydrochloride (GlucaGen®)
1 mg/1 ml of glucagon hydrochloride intramuscularly
Other Name: GlucaGen® (Novo Nordisk Pharma, MA:28288.00.00)
Placebo Comparator: Placebo
1 ml NaCl 0.9%
Drug: NaCl 0.9%
1 ml NaCl 0.9% intramuscularly

Primary Outcome Measures :
  1. Changes in satiety scale, total and acylated ghrelin concentrations. [ Time Frame: During 240 min after Glucagon/Placebo administration. ]

Secondary Outcome Measures :
  1. Changes in glucose, insulin and NEFA concentrations. [ Time Frame: During 240 min after Glucagon/Placebo administration. ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00929812

Charite Campus Benjamin Franklin
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Ayman M Arafat, Charite Campus Benjamin Franklin

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ayman M Arafat,, Charite Campus Benjamin Franklin Identifier: NCT00929812     History of Changes
Other Study ID Numbers: GluGhr-study 01082005
EudoraCT 2005-003714-15
Prüfplancode 01082005
BfArM 61-3910-4031020
EK EA4/108/05
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by Charite University, Berlin, Germany:
food intake

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs