Glucagon Modulation of Ghrelin Secretion

Charité University Medicine Berlin

Status and phase: Unknown; Phase 3

Conditions: Diabetes Mellitus, Type 1; Healthy Subjects; Obesity

Treatments: Drug: Glucagon hydrochloride (GlucaGen®); Drug: NaCl 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT00929812

EudoraCT 2005-003714-15

EK EA4/108/05

GluGhr-study 01082005

BfArM 61-3910-4031020

Prüfplancode 01082005

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

Glucagon hydrochloride

Active Comparator group

Description:

GlucaGen® 1 mg/1 ml intramuscularly

Treatment:

Drug: Glucagon hydrochloride (GlucaGen®)

Placebo

Placebo Comparator group

Description:

1 ml NaCl 0.9%

Treatment:

Drug: NaCl 0.9%