Glucagon Modulation of Ghrelin Secretion

Phase 3

• Conditions: Healthy Subjects; Obesity; Diabetes Mellitus, Type 1
• Interventions: Drug: Glucagon hydrochloride (GlucaGen®); Drug: NaCl 0.9%

• Registration Number: NCT00929812
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-01
• Status Verified: 2009-06
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Last Update Submitted: 2009-06-29
• Study First Posted: 2009-06-30
• Last Update Posted: 2009-06-30
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucagon hydrochloride	Glucagon hydrochloride (GlucaGen®)	GlucaGen® 1 mg/1 ml intramuscularly
Placebo	NaCl 0.9%	1 ml NaCl 0.9%

Primary Outcome Measures

Name	Time	Method
Changes in satiety scale, total and acylated ghrelin concentrations.	During 240 min after Glucagon/Placebo administration.

Secondary Outcome Measures

Name	Time	Method
Changes in glucose, insulin and NEFA concentrations.	During 240 min after Glucagon/Placebo administration.

Trial Locations

Locations (1)

Charite Campus Benjamin Franklin; 🇩🇪 Berlin, Germany