HyperglucagonemiaNCT01436734
Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125
A study testing Fasting glycemia and Hypoglycemia in people with Hyperglucagonemia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study was to investigate the role of the Trasylol in glucagon prevention in degradation using radioimmunoactive method with I125. Additionally different incubation time was introduced in human plasma samples after oral glucose stimulation, also in fasted and hypoglycemia blood samples from patients'… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Hyperglucagonemia
- What is being tested?
- Fasting glycemia and Hypoglycemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2011to May 2013
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasians 18 years or older with Type 2 diabetes (WHO criteria)
Who cannot join
- HbA1c >9 %
- Liver disease (ALAT/ASAT >2 x upper normal limit)
- Diabetic nephropathy (s-creatinine >130 µM or albuminuria)
- Proliferative diabetic retinopathy (anamnestic)
- Severe arteriosclerosis or heart failure (NYHA group III og IV)
- Anemia
Show all 9Show fewer
- treatment with medication not applicable to pause for 12 hours
- pregnancy or lactation
- Fasting plasma glucose >15 mM on screening day.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to investigate the role of the Trasylol in glucagon prevention in degradation using radioimmunoactive method with I125. Additionally different incubation time was introduced in human plasma samples after oral glucose stimulation, also in fasted and hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the techniques for the glucagon measurement are well described nowadays.
- Conditions
- Hyperglucagonemia
- Being tested
- Fasting glycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting glycemiaOther
no intervention
HypoglycemiaOther
Insulin induced hypoglycemia
| Study group | Role | What they receive |
|---|---|---|
| GIP | Experimental | Not described Receives: Other: Fasting glycemia; Other: Hypoglycemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma glucagon values measured with c-terminal specific "micro-protocol" RIA4305: 350µl of plasma (duplicate sample).
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglucagonemiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikkel Christensen, University Hospital, Gentofte, Copenhagen
- Investigators
- Mikkel Christensen, MD, Principal investigator, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436734
- Sponsor's protocol ID
- H-D-2009-0078
- Status last verified
- Jul 2015
- First submitted
- 8 Sep 2011
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125
- ClinicalTrials.gov ID
- NCT01436734
- Acronym / sponsor ID
- H-D-2009-0078
- Conditions
- Hyperglucagonemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Sep 2011 (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 aim of the study was to investigate the role of the Trasylol in glucagon prevention in degradation using radioimmunoactive method with I125. Additionally different incubation time was introduced in human plasma samples after oral glucose stimulation, also in fasted and hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the techniques for the glucagon measurement are well described nowadays.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GIP | Experimental | Other: Fasting glycemia, Other: Hypoglycemia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Caucasians 18 years or older with Type 2 diabetes (WHO criteria)
Key exclusion criteria (9 listed)
- HbA1c >9 %
- Liver disease (ALAT/ASAT >2 x upper normal limit)
- Diabetic nephropathy (s-creatinine >130 µM or albuminuria)
- Proliferative diabetic retinopathy (anamnestic)
- Severe arteriosclerosis or heart failure (NYHA group III og IV)
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 |
|---|---|---|
| Fasting glycemiano intervention | Other | GIP |
| HypoglycemiaInsulin induced hypoglycemia | Other | GIP |
Primary outcome
Change in plasma glucagon values measured with c-terminal specific "micro-protocol" RIA4305: 350µl of plasma (duplicate sample).
Time frame: 120 min
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 14 Jul 2015.
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.
Mikkel Christensen, MD principal investigator
Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting glycemia and Hypoglycemia in people with Hyperglucagonemia, 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 1 inclusion and 9 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 14 Jul 2015. 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?
Change in plasma glucagon values measured with c-terminal specific "micro-protocol" RIA4305: 350µl of plasma (duplicate sample). (time frame: 120 min). 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 14 Jul 2015.