Type 1 DiabetesNCT00832741
Incretin Hormones in Type-1 Diabetes Mellitus Glycemic Response in Type-1 Diabetes Mellitus
An observational study of Type 1 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate whether secretion of incretin hormones is intact and to what extent endogenous as well as exogenous GLP-1 controls postprandial glucose excursions in patients with type-1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- May 2008to Oct 2008
- 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: primary care clinic patients and community population(control subjects)
Who may be able to join
- type-1 diabetes mellitus
- diagnosis between 5-40 years.
- age 18-60 year
- normal weight at time of diagnosis
- insulintreatment from diagnosis
- HbA1c < 7.6 %
Who cannot join
- diabetic complications
- disease other than type-1 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Secretion and Significance of the Incretin Hormones on the Postprandial Glycemic Response in Type-1 Diabetes Mellitus
The purpose of this study is to investigate whether secretion of incretin hormones is intact and to what extent endogenous as well as exogenous GLP-1 controls postprandial glucose excursions in patients with type-1 diabetes mellitus.
Read the detailed description
GLP-1 and GIP are incretin hormones secreted from specific endocrine celles in the gut. Stimulus for secretion is prescence of carbohydrates, fat and protein in the gut. The incretin hormones controls postprandial glucose excursions through stimulation of insulinsecretion as well as inhibition of glucagon and gastric emptying.The effects of GLP-1 on insulin secretion and glucagon inhibition are glucose dependent and the risc of hypoglycemia is therefore negligible when the hormone is administered in supra physiological concentrations.Furthermore, some animal studies suggest that GLP-1 has a trofic effect on the betacells and the hormone has been shown to replenish intracellular stores of insulin. Because the main bloodglucose lowering effect of GLP-1 has been thought to be due to increased insulin secretion, analouges of the hormone has been developed for the treatment of type-2 diabetes. So far, relatively little is known about the effect of GLP-1 in type-1 diabetes.It possible, that GLP-1 in combination with insulin (possibly mainly through its effect on glucagon inhibition and gastric emptying) could reduce the need for exogenous insulin with a concomitant reduced risc of hypoglycemia. Without compromising the target glucemic control. This study focuses of the postprandial bloodglucose lowering effects of endogenous as well as exogenous GLP-1 in patients with type-1 diabetes according to residual betacell function and glycemic control.Furthermore, the endogenous secretion of incretin hormones in patients with type-1 diabetes mellitus will be compared to that of matched normal controls.
- Conditions
- Type 1 Diabetes
- Keywords
- GLP-1, Type 1 diabetes, Glycemic control, Incretin hormone
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
Measured: 4 hours
Secondary outcomes (4)
GLP-1 and GIP response during a meal
Measured: 4 hours
betacell function (incremental area under the c-peptide concentration curve)
Measured: 4 hours
alfa cell function (plasma glucagon)
Measured: 4 hours
gastric emptying
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startMay 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Observational
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Urd Kielgast, MD, Study director, unafilliatedSten Madsbad, MD, DMSc, Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832741
- Sponsor's protocol ID
- H-C-2007-0080
- Other IDs
- 2008-41-1811
- Status last verified
- Jan 2009
- First submitted
- 29 Jan 2009
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secretion and Significance of the Incretin Hormones on the Postprandial Glycemic Response in Type-1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00832741
- Acronym / sponsor ID
- H-C-2007-0080
- Conditions
- Type 1 Diabetes
- Keywords
- GLP-1, Type 1 diabetes, Glycemic control, Incretin hormone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 Jan 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.
The purpose of this study is to investigate whether secretion of incretin hormones is intact and to what extent endogenous as well as exogenous GLP-1 controls postprandial glucose excursions in patients with type-1 diabetes mellitus.
Detailed description
GLP-1 and GIP are incretin hormones secreted from specific endocrine celles in the gut. Stimulus for secretion is prescence of carbohydrates, fat and protein in the gut. The incretin hormones controls postprandial glucose excursions through stimulation of insulinsecretion as well as inhibition of glucagon and gastric emptying.The effects of GLP-1 on insulin secretion and glucagon inhibition are glucose dependent and the risc of hypoglycemia is therefore negligible when the hormone is administered in supra physiological concentrations.Furthermore, some animal studies suggest that GLP-1 has a trofic effect on the betacells and the hormone has been shown to replenish intracellular stores of insulin. Because the main bloodglucose lowering effect of GLP-1 has been thought to be due to increased insulin secretion, analouges of the hormone has been developed for the treatment of type-2 diabetes. So far, relatively little is known about the effect of GLP-1 in type-1 diabetes.It possible, that GLP-1 in combination with insulin (possibly mainly through its effect on glucagon inhibition and gastric emptying) could reduce the need for exogenous insulin with a concomitant reduced risc of hypoglycemia. Without compromising the target glucemic control. This study focuses of the postprandial bloodglucose lowering effects of endogenous as well as exogenous GLP-1 in patients with type-1 diabetes according to residual betacell function and glycemic control.Furthermore, the endogenous secretion of incretin hormones in patients with type-1 diabetes mellitus will be compared to that of matched normal controls.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- primary care clinic patients and community population(control subjects)
Key inclusion criteria (6 listed)
- type-1 diabetes mellitus
- diagnosis between 5-40 years.
- age 18-60 year
- normal weight at time of diagnosis
- insulintreatment from diagnosis
Key exclusion criteria (2 listed)
- diabetic complications
- disease other than type-1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood glucose
Time frame: 4 hours
4 secondary outcomes
GLP-1 and GIP response during a meal
Time frame: 4 hours
betacell function (incremental area under the c-peptide concentration curve)
Time frame: 4 hours
alfa cell function (plasma glucagon)
Time frame: 4 hours
gastric emptying
Time frame: 4 hours
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 30 Jan 2009.
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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.
Urd Kielgast, MD study director
unafilliated
Sten Madsbad, MD, DMSc principal investigator
Unafilliated
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 Type 1 Diabetes, run by Hvidovre University Hospital 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 6 inclusion and 2 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 30 Jan 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 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?
blood glucose (time frame: 4 hours). 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 30 Jan 2009.