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Glucagon Modulation of Ghrelin Secretion

NCT ID: NCT00929812

Last Updated: 2009-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-12-31

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.

Detailed Description

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Conditions

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Healthy Subjects Obesity Diabetes Mellitus, Type 1

Keywords

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obesity food intake glucagon ghrelin glucose insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Glucagon hydrochloride

GlucaGen® 1 mg/1 ml intramuscularly

Group Type ACTIVE_COMPARATOR

Glucagon hydrochloride (GlucaGen®)

Intervention Type DRUG

1 mg/1 ml of glucagon hydrochloride intramuscularly

Placebo

1 ml NaCl 0.9%

Group Type PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type DRUG

1 ml NaCl 0.9% intramuscularly

Interventions

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Glucagon hydrochloride (GlucaGen®)

1 mg/1 ml of glucagon hydrochloride intramuscularly

Intervention Type DRUG

NaCl 0.9%

1 ml NaCl 0.9% intramuscularly

Intervention Type DRUG

Other Intervention Names

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GlucaGen® (Novo Nordisk Pharma, MA:28288.00.00)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charite Campus Benjamin Franklin

Principal Investigators

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Ayman M Arafat, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Charite Campus Benjamin Franklin

Locations

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Charite Campus Benjamin Franklin

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 16787987 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23966238 (View on PubMed)

Other Identifiers

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EudoraCT 2005-003714-15

Identifier Type: -

Identifier Source: secondary_id

Prüfplancode 01082005

Identifier Type: -

Identifier Source: secondary_id

BfArM 61-3910-4031020

Identifier Type: -

Identifier Source: secondary_id

EK EA4/108/05

Identifier Type: -

Identifier Source: secondary_id

GluGhr-study 01082005

Identifier Type: -

Identifier Source: org_study_id