Back to resultsGlucagon Modulation of Ghrelin Secretion
Primary Purpose
Healthy Subjects, Obesity, Diabetes Mellitus, Type 1
Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Glucagon hydrochloride (GlucaGen®)
NaCl 0.9%
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Subjects focused on measuring obesity, food intake, glucagon, ghrelin, glucose, insulin
Eligibility 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
Sites / Locations
- Charite Campus Benjamin Franklin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glucagon hydrochloride
Placebo
Arm Description
GlucaGen® 1 mg/1 ml intramuscularly
1 ml NaCl 0.9%
Outcomes
Primary Outcome Measures
Changes in satiety scale, total and acylated ghrelin concentrations.
Secondary Outcome Measures
Changes in glucose, insulin and NEFA concentrations.
Full Information
NCT ID
NCT00929812
First Posted
June 29, 2009
Last Updated
June 29, 2009
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00929812
Brief Title
Glucagon Modulation of Ghrelin Secretion
Official Title
The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Obesity, Diabetes Mellitus, Type 1
Keywords
obesity, food intake, glucagon, ghrelin, glucose, insulin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucagon hydrochloride
Arm Type
Active Comparator
Arm Description
GlucaGen® 1 mg/1 ml intramuscularly
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 ml NaCl 0.9%
Intervention Type
Drug
Intervention Name(s)
Glucagon hydrochloride (GlucaGen®)
Other Intervention Name(s)
GlucaGen® (Novo Nordisk Pharma, MA:28288.00.00)
Intervention Description
1 mg/1 ml of glucagon hydrochloride intramuscularly
Intervention Type
Drug
Intervention Name(s)
NaCl 0.9%
Intervention Description
1 ml NaCl 0.9% intramuscularly
Primary Outcome Measure Information:
Title
Changes in satiety scale, total and acylated ghrelin concentrations.
Time Frame
During 240 min after Glucagon/Placebo administration.
Secondary Outcome Measure Information:
Title
Changes in glucose, insulin and NEFA concentrations.
Time Frame
During 240 min after Glucagon/Placebo administration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman M Arafat, Dr.med.
Organizational Affiliation
Charite Campus Benjamin Franklin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16787987
Citation
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.
Results Reference
background
PubMed Identifier
23966238
Citation
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.
Results Reference
derived
Learn more about this trial
Glucagon Modulation of Ghrelin Secretion
We'll reach out to this number within 24 hrs