Glucagon Modulation of Ghrelin Secretion

June 29, 2009 updated by: Charite University, Berlin, Germany

The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 12200
        • Charite Campus Benjamin Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glucagon hydrochloride
GlucaGen® 1 mg/1 ml intramuscularly
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%
1 ml NaCl 0.9% intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in satiety scale, total and acylated ghrelin concentrations.
Time Frame: During 240 min after Glucagon/Placebo administration.
During 240 min after Glucagon/Placebo administration.

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in glucose, insulin and NEFA concentrations.
Time Frame: During 240 min after Glucagon/Placebo administration.
During 240 min after Glucagon/Placebo administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimate)

June 30, 2009

Study Record Updates

Last Update Posted (Estimate)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 29, 2009

Last Verified

June 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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