HyperglucagonemiaNCT00704795
Glucagon Responses During Oral- and iv Glucose in Patients With Type 1 Diabetes
An observational study of Hyperglucagonemia and Hyperglycemia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
In order to evaluate the potential role of the gastrointestinal (GI) tract in the postprandial hyperglucagonemia, which characterizes type 1 diabetes mellitus (T1DM) (as well as type 2 diabetes mellitus (T2DM)), we wish to investigate the secretion of glucagon in patients with T1DM without residual beta-cell function… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglucagonemia, Hyperglycemia, Diabetes Mellitus
- What is being tested?
- Oral glucose tolerance test and Isoglycemic iv glucose infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2008to Oct 2009
- Phase
- Observational
- 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
Study population: Patients with type 1 diabetes mellitus and no residual beta-cell function (C-peptide negative)
Who may be able to join
- Caucasian over 18 years with T1DM (diagnosed according to WHO's criteria) treated with long-acting insulin
- No residual beta-cell function (arginine test without increment in plasma C-peptide - see below)
- BMI <30 kg/m2
- Normal haemoglobin
- Informed consent
Who cannot join
- Residual beta-cell function (increment in plasma C-peptide during arginine test - see below)
- Known liver disease or affected liver enzymes (ALAT/ASAT > 2 x upper normal limit)
- Diabetic nephropathy (se-creatinin > 130 µM and/or albuminuria)
- Proliferative diabetic retinopathy (anamnestic)
- Treatment with medication that cannot be discontinued for 14 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucagon Responses Following Oral Glucose and Isoglycemic iv Glucose in Patients With Type 1 Diabetes - a Role for the Gastrointestinal Tract in Diabetic Hyperglucagonemia?
In order to evaluate the potential role of the gastrointestinal (GI) tract in the postprandial hyperglucagonemia, which characterizes type 1 diabetes mellitus (T1DM) (as well as type 2 diabetes mellitus (T2DM)), we wish to investigate the secretion of glucagon in patients with T1DM without residual beta-cell function during 50-g oral glucose tolerance test (OGTT) and during isoglycemic iv glucose infusion. By evaluating C-peptide negative patients with T1DM we aim to describe the glucagon response to glucose (+/-stimulation of the GI tract) independently of the potentially very important regulation of glucagon secretion by endogenous insulin secretion. A more detailed understanding of the inappropriate glucagon secretion in T1DM is highly needed in order to establish new intervention strategies in the future treatment of the growing numbers of T1DM patients.
- Conditions
- Hyperglucagonemia, Hyperglycemia, Diabetes Mellitus
- Being tested
- Oral glucose tolerance test, Isoglycemic iv glucose infusion
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testOther
Also called OGTT, 50 g-OGTT
50 g of waterfree glucose dissolved in 300 ml water is ingested over 5 minutes following a 10-h fast including liquids and medication (if any).
Isoglycemic iv glucose infusionOther
Also called Isoglycemic IVGTT
The plasma glucose curve obtained during a 50 g-OGTT (performed on a separate day) is copied using an adjustable iv glucose infusion (20% w/v) performed following a 10-h fast including liquids and medication (if any). The iv catheter is inserted into a peripheral vein in the hand/forearm.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with type 1 diabetes mellitus Receives: Other: Oral glucose tolerance test; Other: Isoglycemic iv glucose infusion | |
| 2 | Healthy control subjects matched for body mass index (BMI), age and gender. Receives: Other: Oral glucose tolerance test; Other: Isoglycemic iv glucose infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon responses (as assessed by area under curve (AUC)) during 50-g oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion, respectively.
Measured: months
Secondary outcomes (2)
Responses of glucagon-like peptide-1 (GLP-1), glucagon-like peptide-2 (GLP-2) and glucose-dependent insulinotropic polypeptide (GIP) as assessed by AUC during 50-g OGTT and isoglycemic iv glucose infusion, respectively.
Measured: months
GI-mediated glucose tolerance as assessed by the amount of glucose ingested as compared to the amount of glucose needed to mimic the OGTT curve during the iv glucose infusion.
Measured: Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2009 (estimated)
- Study completionOct 2009 (estimated)
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
- Observational
- Observational model
- Case-control
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Filip K Knop, MD PhD, Principal investigator, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704795
- Sponsor's protocol ID
- H-D-2008-037
- Status last verified
- Jun 2008
- First submitted
- 24 Jun 2008
- Last updated
- 26 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon Responses Following Oral Glucose and Isoglycemic iv Glucose in Patients With Type 1 Diabetes - a Role for the Gastrointestinal Tract in Diabetic Hyperglucagonemia?
- ClinicalTrials.gov ID
- NCT00704795
- Acronym / sponsor ID
- H-D-2008-037
- Conditions
- Hyperglucagonemia, Hyperglycemia, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 25 Jun 2008 (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.
In order to evaluate the potential role of the gastrointestinal (GI) tract in the postprandial hyperglucagonemia, which characterizes type 1 diabetes mellitus (T1DM) (as well as type 2 diabetes mellitus (T2DM)), we wish to investigate the secretion of glucagon in patients with T1DM without residual beta-cell function during 50-g oral glucose tolerance test (OGTT) and during isoglycemic iv glucose infusion. By evaluating C-peptide negative patients with T1DM we aim to describe the glucagon response to glucose (+/-stimulation of the GI tract) independently of the potentially very important regulation of glucagon secretion by endogenous insulin secretion. A more detailed understanding of the inappropriate glucagon secretion in T1DM is highly needed in order to establish new intervention strategies in the future treatment of the growing numbers of T1DM patients.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Oral glucose tolerance test, Other: Isoglycemic iv glucose infusionPatients with type 1 diabetes mellitus |
| 2 | – | Other: Oral glucose tolerance test, Other: Isoglycemic iv glucose infusionHealthy control subjects matched for body mass index (BMI), age and gender. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with type 1 diabetes mellitus and no residual beta-cell function (C-peptide negative)
Key inclusion criteria (5 listed)
- Caucasian over 18 years with T1DM (diagnosed according to WHO's criteria) treated with long-acting insulin
- No residual beta-cell function (arginine test without increment in plasma C-peptide - see below)
- BMI <30 kg/m2
- Normal haemoglobin
- Informed consent
Key exclusion criteria (5 listed)
- Residual beta-cell function (increment in plasma C-peptide during arginine test - see below)
- Known liver disease or affected liver enzymes (ALAT/ASAT > 2 x upper normal limit)
- Diabetic nephropathy (se-creatinin > 130 µM and/or albuminuria)
- Proliferative diabetic retinopathy (anamnestic)
- Treatment with medication that cannot be discontinued for 14 hours
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 |
|---|---|---|
| Oral glucose tolerance testAlso: OGTT, 50 g-OGTT50 g of waterfree glucose dissolved in 300 ml water is ingested over 5 minutes following a 10-h fast including liquids and medication (if any). | Other | 1, 2 |
| Isoglycemic iv glucose infusionAlso: Isoglycemic IVGTTThe plasma glucose curve obtained during a 50 g-OGTT (performed on a separate day) is copied using an adjustable iv glucose infusion (20% w/v) performed following a 10-h fast including liquids and medication (if any). The iv catheter is inserted into a peripheral vein in the hand/forearm. | Other | 1, 2 |
Primary outcome
Glucagon responses (as assessed by area under curve (AUC)) during 50-g oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion, respectively.
Time frame: months
2 secondary outcomes
Responses of glucagon-like peptide-1 (GLP-1), glucagon-like peptide-2 (GLP-2) and glucose-dependent insulinotropic polypeptide (GIP) as assessed by AUC during 50-g OGTT and isoglycemic iv glucose infusion, respectively.
Time frame: months
GI-mediated glucose tolerance as assessed by the amount of glucose ingested as compared to the amount of glucose needed to mimic the OGTT curve during the iv glucose infusion.
Time frame: Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2008.
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.
Filip K Knop, MD PhD principal investigator
University Hospital, Gentofte, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglucagonemia and Hyperglycemia, 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 5 inclusion and 5 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 26 Jun 2008. 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?
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?
Glucagon responses (as assessed by area under curve (AUC)) during 50-g oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion, respectively. (time frame: months). 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 26 Jun 2008.