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Glucagon Modulation of Ghrelin Secretion

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Unknown status
CT.gov ID
NCT00929812
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
42
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Glucagon hydrochloride (GlucaGen®)
  • Drug: NaCl 0.9%
 Phase 3

Study Design

Study Type:
Interventional
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 :
Jun 1, 2006
Actual Primary Completion Date :
Jan 1, 2008
Anticipated Study Completion Date :
Dec 1, 2009

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Changes in satiety scale, total and acylated ghrelin concentrations. [During 240 min after Glucagon/Placebo administration.]

    Secondary Outcome Measures

    1. Changes in glucose, insulin and NEFA concentrations. [During 240 min after Glucagon/Placebo administration.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charite Campus Benjamin Franklin Berlin Germany 12200

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00929812
    Other Study ID Numbers:
    • GluGhr-study 01082005
    • EudoraCT 2005-003714-15
    • Prüfplancode 01082005
    • BfArM 61-3910-4031020
    • EK EA4/108/05
    First Posted:
    Jun 30, 2009
    Last Update Posted:
    Jun 30, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    obesity
    food intake
    glucagon
    ghrelin
    glucose
    insulin
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 1
    Glucagon

    Study Results

    No Results Posted as of Jun 30, 2009