Overview

This trial is active, not recruiting.

Conditions healthy subjects, obesity, diabetes mellitus, type 1
Treatments glucagon hydrochloride (glucagen®), nacl 0.9%
Phase phase 3
Sponsor Charite University, Berlin, Germany
Start date June 2006
End date January 2008
Trial size 38 participants
Trial identifier NCT00929812, BfArM 61-3910-4031020, EK EA4/108/05, EudoraCT 2005-003714-15, GluGhr-study 01082005, Prüfplancode 01082005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose basic science
Arm
(Active Comparator)
GlucaGen® 1 mg/1 ml intramuscularly
glucagon hydrochloride (glucagen®) GlucaGen® (Novo Nordisk Pharma, MA:28288.00.00)
1 mg/1 ml of glucagon hydrochloride intramuscularly
(Placebo Comparator)
1 ml NaCl 0.9%
nacl 0.9% NaCl 0.9%
1 ml NaCl 0.9% intramuscularly

Primary Outcomes

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

Secondary Outcomes

Measure
Changes in glucose, insulin and NEFA concentrations.
time frame: During 240 min after Glucagon/Placebo administration.

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion
Principal investigator Ayman M Arafat, Dr.med.
Trial information was received from ClinicalTrials.gov and was last updated in June 2009.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.