Glucagon Modulation of Ghrelin Secretion

Study Overview
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Brief Summary
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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.

Official Title
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The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion

Conditions
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Healthy Subjects, Obesity, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Glucagon hydrochloride (GlucaGen®)
* Drug: NaCl 0.9%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucagon hydrochloride<br>GlucaGen® 1 mg/1 ml intramuscularly | Drug: Glucagon hydrochloride (GlucaGen®)<br>* 1 mg/1 ml of glucagon hydrochloride intramuscularly<br>* Other names: GlucaGen® (Novo Nordisk Pharma, MA:28288.00.00);|
| Placebo Comparator: Placebo<br>1 ml NaCl 0.9% | Drug: NaCl 0.9%<br>* 1 ml NaCl 0.9% intramuscularly<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, food intake, glucagon, ghrelin, glucose, insulin