- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00929812
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
Status
Unknown
Conditions
Intervention / Treatment
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:
|
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.
General Publications
- Arafat AM, Perschel FH, Otto B, Weickert MO, Rochlitz H, Schofl C, Spranger J, Mohlig M, Pfeiffer AF. Glucagon suppression of ghrelin secretion is exerted at hypothalamus-pituitary level. J Clin Endocrinol Metab. 2006 Sep;91(9):3528-33. doi: 10.1210/jc.2006-0225. Epub 2006 Jun 20.
- Arafat AM, Weickert MO, Adamidou A, Otto B, Perschel FH, Spranger J, Mohlig M, Pfeiffer AF. The impact of insulin-independent, glucagon-induced suppression of total ghrelin on satiety in obesity and type 1 diabetes mellitus. J Clin Endocrinol Metab. 2013 Oct;98(10):4133-42. doi: 10.1210/jc.2013-1635. Epub 2013 Aug 21.
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GluGhr-study 01082005
- EudoraCT 2005-003714-15
- Prüfplancode 01082005
- BfArM 61-3910-4031020
- EK EA4/108/05
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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