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Trial · Interventional

Status unknownPhase 3Registry data

Glucagon Modulation of Ghrelin Secretion

NCTNCT00929812 (opens ClinicalTrials.gov in a new tab)Other idGluGhr-study 01082005Other idEudoraCT 2005-003714-15Other idPrüfplancode 01082005Other idBfArM 61-3910-4031020
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
38 participants (actual)
Sponsor
Charite University, Berlin, Germany · Other
Design
Randomized · Triple masking
Countries
1 country

Germany

Start
Jun 2006
Primary completion
Jan 2008
Completion
Dec 2009 (estimated)
First posted
30 Jun 2009 (estimated)
Last update posted
30 Jun 2009 (estimated)
Conditions
Healthy Subjects · Obesity · Diabetes Mellitus, Type 1

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007200820092010
  1. Ph 3

    Glucagon Modulation of Ghrelin Secretion

    NCT00929812

    Jun 2006 to est. Dec 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Glucagon hydrochloride (GlucaGen®)Drug
  • NaCl 0.9%Drug

Arms2

  • Active comparator

    Glucagon hydrochloride

    GlucaGen® 1 mg/1 ml intramuscularly

  • Placebo comparator

    Placebo

    1 ml NaCl 0.9%

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Changes in satiety scale, total and acylated ghrelin concentrations.

    Time frame · During 240 min after Glucagon/Placebo administration.

Secondary outcomes(1)

  1. Changes in glucose, insulin and NEFA concentrations.

    Time frame · During 240 min after Glucagon/Placebo administration.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2013

10 results

The impact of insulin-independent, glucagon-induced suppression of total ghrelin on satiety in obesity and type 1 diabetes mellitus.

Arafat et al. 2013The Journal of clinical endocrinology and metabolismcited by 19

PMID 23966238DOI 10.1210/jc.2013-1635PUB-23966238

Rights unknown10 results
Source linkSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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