DiabetesMCR GlucagonNCT02475421
Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance
A study testing Glucagon in people with Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The study aims to evaluate the elimination and degradation of glucagon in patients with type 2 diabetes compared to matched healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Glucagon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to Jan 2017
- Phase
- Interventional
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes
- Caucasians above 35 years of age with diet or/and metformin-treated type 2 diabetes of at least 3 month duration (diagnosed according to World Health Organization (WHO) criteria
- BMI either below 27 or above 33 kg/m^2
- Normal haemoglobin
- Informed consent
- Subjects with NGT
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- Caucasians above 35 years of age
- BMI either below 27 or above 33 kg/m^2
- Normal HbA1c (according to WHO criteria)
- Normal haemoglobin
- Informed consent
Who cannot join
- Patients with type 2 diabetes
- Inflammatory bowel disease
- Operation within the last 3 months
- Severe kidney disease (eGFR < 60 ml/min)
- Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2×normal values)
- Pregnancy and/or breastfeeding
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- Age above 80 years
- Any condition that the investigators feel would interfere with trial participation
- Subjects with NGT
- Diabetes
- Prediabetes (impaired FPG or HbA1c above 42 mmol/mol)
- First-degree relatives with diabetes
- Inflammatory bowel disease
- Intestinal resection
- Severe kidney disease (eGFR < 60 ml/min)
- Liver disease (ALA T and/or serum ASA T >2×normal values)
- Pregnancy and/or breastfeeding
- Age above 80 years Any condition that the investigators feel would interfere with trial participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Diabetes Research, Department of Medicine, Gentofte Hospital
Hellerup, Copenhagen, 2900
About this study
The study aims to evaluate the elimination and degradation of glucagon in patients with type 2 diabetes compared to matched healthy subjects.
Read the detailed description
In the present project the investigators wish to identify whether the elimination and degradation of glucagon differ between healthy control subjects and patients with type 2 diabetes. Furthermore, the investigators wish to examine whether obesity is an independent factor for altered glucagon metabolism. Thus, by examining glucagon elimination in obese subjects with and without type 2 diabetes and in lean subjects with and without type 2 diabetes the investigators will be able to describe the metabolic clearance rate (MCR) of glucagon in a broad spectrum of individuals with different levels of insulin resistance and beta cell dysfunction.
- Conditions
- Diabetes
- Being tested
- Glucagon
- Keywords
- Diabetes, Glucagon, Metabolic clearance rate of glucagon
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonBiological
One hour glucagon-clamp followed by one hour of blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Healthy, lean subjects | Experimental | Healthy subjects with BMI < 27 kg/m^2 Receives: Biological: Glucagon |
| Healthy, obese subjects | Experimental | Healthy subjects with BMI > 33 kg/m^2 Receives: Biological: Glucagon |
| Diabetic, lean subjects | Experimental | Diabetic subjects with BMI < 27 kg/m^2 Receives: Biological: Glucagon |
| Diabetic, obese subjects | Experimental | Diabetic subjects with BMI > 33 kg/m^2 Receives: Biological: Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic clearance rate of glucagon
Measured: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Secondary outcomes (6)
Gut and pancreatic hormones
Measured: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Blood glucose
Measured: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Basic metabolic rate
Measured: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Satiety, hunger, appetite - measured with visual analogue scales (VAS)
Measured: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Half life of glucagon
Measured: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
The volume of distribution of glucagon
Measured: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, European Foundation for the Study of Diabetes
- Responsible party
- Principal investigator, Asger Lund, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475421
- Sponsor's protocol ID
- H-1-2014-066
- Acronym
- MCR Glucagon
- Status last verified
- Oct 2018
- First submitted
- 11 Jun 2015
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance
- ClinicalTrials.gov ID
- NCT02475421
- Acronym / sponsor ID
- MCR Glucagon / H-1-2014-066
- Conditions
- Diabetes
- Keywords
- Diabetes, Glucagon, Metabolic clearance rate of glucagon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen, European Foundation for the Study of Diabetes
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Jun 2015 (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.
The study aims to evaluate the elimination and degradation of glucagon in patients with type 2 diabetes compared to matched healthy subjects.
Detailed description
In the present project the investigators wish to identify whether the elimination and degradation of glucagon differ between healthy control subjects and patients with type 2 diabetes. Furthermore, the investigators wish to examine whether obesity is an independent factor for altered glucagon metabolism. Thus, by examining glucagon elimination in obese subjects with and without type 2 diabetes and in lean subjects with and without type 2 diabetes the investigators will be able to describe the metabolic clearance rate (MCR) of glucagon in a broad spectrum of individuals with different levels of insulin resistance and beta cell dysfunction.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy, lean subjects | Experimental | Biological: GlucagonHealthy subjects with BMI < 27 kg/m^2 |
| Healthy, obese subjects | Experimental | Biological: GlucagonHealthy subjects with BMI > 33 kg/m^2 |
| Diabetic, lean subjects | Experimental | Biological: GlucagonDiabetic subjects with BMI < 27 kg/m^2 |
| Diabetic, obese subjects | Experimental | Biological: GlucagonDiabetic subjects with BMI > 33 kg/m^2 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with type 2 diabetes
- Caucasians above 35 years of age with diet or/and metformin-treated type 2 diabetes of at least 3 month duration (diagnosed according to World Health Organization (WHO) criteria
- BMI either below 27 or above 33 kg/m^2
- Normal haemoglobin
- Informed consent
Key exclusion criteria (18 listed)
- Patients with type 2 diabetes
- Inflammatory bowel disease
- Operation within the last 3 months
- Severe kidney disease (eGFR < 60 ml/min)
- Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2×normal values)
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 |
|---|---|---|
| GlucagonOne hour glucagon-clamp followed by one hour of blood sampling | Biological | Diabetic, lean subjects, Diabetic, obese subjects, Healthy, lean subjects, Healthy, obese subjects |
Primary outcome
Metabolic clearance rate of glucagon
Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
6 secondary outcomes
Gut and pancreatic hormones
Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Blood glucose
Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Basic metabolic rate
Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Satiety, hunger, appetite - measured with visual analogue scales (VAS)
Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Half life of glucagon
Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
The volume of distribution of glucagon
Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucagon in people with Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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 11 inclusion and 18 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: finished, as of the sponsor's last update on 15 Oct 2018. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Metabolic clearance rate of glucagon (time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2018.