Healthy SubjectsPhase 3NCT00929812
Glucagon Modulation of Ghrelin Secretion
A Phase 3 study testing Glucagon hydrochloride (GlucaGen®) and NaCl 0.9% in people with Healthy Subjects and Obesity, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Obesity, Diabetes Mellitus, Type 1
- What is being tested?
- Glucagon hydrochloride (GlucaGen®) and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion
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.
- Conditions
- Healthy Subjects, Obesity, Diabetes Mellitus, Type 1
- Being tested
- Glucagon hydrochloride (GlucaGen®), NaCl 0.9%
- Keywords
- obesity, food intake, glucagon, ghrelin, glucose, insulin
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon hydrochloride (GlucaGen®)Drug
Also called GlucaGen® (Novo Nordisk Pharma, MA:28288.00.00)
1 mg/1 ml of glucagon hydrochloride intramuscularly
NaCl 0.9%Drug
1 ml NaCl 0.9% intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Glucagon hydrochloride | Active comparator | GlucaGen® 1 mg/1 ml intramuscularly Receives: Drug: Glucagon hydrochloride (GlucaGen®) |
| Placebo | Placebo comparator | 1 ml NaCl 0.9% Receives: Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in satiety scale, total and acylated ghrelin concentrations.
Measured: During 240 min after Glucagon/Placebo administration.
Secondary outcomes (1)
Changes in glucose, insulin and NEFA concentrations.
Measured: During 240 min after Glucagon/Placebo administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2006
- Primary completionJan 2008
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Ayman M Arafat, Dr.med., Principal investigator, Charite Campus Benjamin Franklin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929812
- Sponsor's protocol ID
- GluGhr-study 01082005
- Other IDs
- EudoraCT 2005-003714-15, Prüfplancode 01082005, BfArM 61-3910-4031020, EK EA4/108/05
- Status last verified
- Jun 2009
- First submitted
- 29 Jun 2009
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16787987Arafat 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.
PubMed 23966238
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion
- ClinicalTrials.gov ID
- NCT00929812
- Acronym / sponsor ID
- GluGhr-study 01082005
- Conditions
- Healthy Subjects, Obesity, Diabetes Mellitus, Type 1
- Keywords
- obesity, food intake, glucagon, ghrelin, glucose, insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucagon hydrochloride | Active comparator | Drug: Glucagon hydrochloride (GlucaGen®)GlucaGen® 1 mg/1 ml intramuscularly |
| Placebo | Placebo comparator | Drug: NaCl 0.9%1 ml NaCl 0.9% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects > 18 and < 60 years old.
- Patients with diabetes type 1 should fulfill the following criteria:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucagon hydrochloride (GlucaGen®)Also: GlucaGen® (Novo Nordisk Pharma, MA:28288.00.00)1 mg/1 ml of glucagon hydrochloride intramuscularly | Drug | Glucagon hydrochloride |
| NaCl 0.9%1 ml NaCl 0.9% intramuscularly | Drug | Placebo |
Primary outcome
Changes in satiety scale, total and acylated ghrelin concentrations.
Time frame: During 240 min after Glucagon/Placebo administration.
1 secondary outcome
Changes in glucose, insulin and NEFA concentrations.
Time frame: During 240 min after Glucagon/Placebo administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
- Background: PubMed 16787987Arafat 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.
- Derived from this study: PubMed 23966238Arafat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman M Arafat, Dr.med. principal investigator
Charite Campus Benjamin Franklin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glucagon hydrochloride (GlucaGen®) and NaCl 0.9% in people with Healthy Subjects and Obesity, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in satiety scale, total and acylated ghrelin concentrations. (time frame: During 240 min after Glucagon/Placebo administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00929812, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2009.