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Glucagon Modulation of Ghrelin Secretion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00929812
First received: June 29, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion

Resource links provided by NLM:

Drug Information available for: Glucagon
U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Changes in satiety scale, total and acylated ghrelin concentrations. [ Time Frame: During 240 min after Glucagon/Placebo administration. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in glucose, insulin and NEFA concentrations. [ Time Frame: During 240 min after Glucagon/Placebo administration. ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: June 2006
Estimated Study Completion Date: December 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: NaCl 0.9%

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929812

Locations
Germany
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
  More Information

Additional Information:
Department website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Ayman M Arafat, Dr.med., Charite Campus Benjamin Franklin
ClinicalTrials.gov 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
Study First Received: June 29, 2009
Last Updated: June 29, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
obesity
food intake
glucagon
 ghrelin
glucose
insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Glucagon
Glucagon-Like Peptide 1
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins

ClinicalTrials.gov processed this record on May 23, 2013