Incretin EffectBMI-INKNCT00803296
Incretin Effect in Lean and Obese Subjects
An observational study of Incretin Effect and Insulin Resistance, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the notion that this deficiency is a consequence of the diabetic state. However, the impact of insulin resistance on the incretin effect in obese individuals who uphold a normal glucose tolerance (NGT) despite their insulin… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Incretin Effect, Insulin Resistance, Type 2 Diabetes
- What is being tested?
- Oral glucose tolerance test (OGTT) and Isoglycemic intravenous glucose infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Jun 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lean and obese patients with type 2 diabetes; and matched healthy control subjects.
Who may be able to join
- Diagnosed with type 2 diabetes for at least 3 months
- Normal blood hemoglobin
- Informed consent
Who cannot join
- Liver disease
- Diabetic nephropathy
- Treatment with medication that can not be stopped for 12 hours
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Gentofte Hospital, University of Copenhagen
Hellerup, Copenhagen, 2900
About this study
Official title: The Impact of Obesity and Insulin Resistance on the Incretin Effect in Patients With Type 2 Diabetes and Healthy Subjects
The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the notion that this deficiency is a consequence of the diabetic state. However, the impact of insulin resistance on the incretin effect in obese individuals who uphold a normal glucose tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary aim of the present study is to evaluate the separate impact of one of the cornerstones of type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of healthy control subjects.
- Conditions
- Incretin Effect, Insulin Resistance, Type 2 Diabetes
- Being tested
- Oral glucose tolerance test (OGTT), Isoglycemic intravenous glucose infusion
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance test (OGTT)Other
Isoglycemic intravenous glucose infusionOther
| Study group | Role | What they receive |
|---|---|---|
| Obese patients with type 2 diabetes | Patients with type 2 diabetes and BMI>33 Receives: Other: Oral glucose tolerance test (OGTT); Other: Isoglycemic intravenous glucose infusion | |
| Obese subjects with normal glucose tolerance | Subjects with normal glucose tolerance and BMI>33 Receives: Other: Oral glucose tolerance test (OGTT); Other: Isoglycemic intravenous glucose infusion | |
| Lean subjects with type 2 diabetes | Patients with type 2 diabetes and BM<25 Receives: Other: Oral glucose tolerance test (OGTT); Other: Isoglycemic intravenous glucose infusion | |
| Lean subjects with normal glucose tolerance | Subjects with normal glucose tolerance and BM<25 Receives: Other: Oral glucose tolerance test (OGTT); Other: Isoglycemic intravenous glucose infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incretin effect
Measured: 2 days
Secondary outcomes (1)
Insulin resistance
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startJan 2006
- Primary completionJan 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incretin EffectStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Tina Vilsbøll, MD DMSc, Study chair, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803296
- Sponsor's protocol ID
- BMI-INK
- Acronym
- BMI-INK
- Status last verified
- Dec 2008
- First submitted
- 4 Dec 2008
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Obesity and Insulin Resistance on the Incretin Effect in Patients With Type 2 Diabetes and Healthy Subjects
- ClinicalTrials.gov ID
- NCT00803296
- Acronym / sponsor ID
- BMI-INK / BMI-INK
- Conditions
- Incretin Effect, Insulin Resistance, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Dec 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.
The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the notion that this deficiency is a consequence of the diabetic state. However, the impact of insulin resistance on the incretin effect in obese individuals who uphold a normal glucose tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary aim of the present study is to evaluate the separate impact of one of the cornerstones of type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of healthy control subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese patients with type 2 diabetes | – | Other: Oral glucose tolerance test (OGTT), Other: Isoglycemic intravenous glucose infusionPatients with type 2 diabetes and BMI>33 |
| Obese subjects with normal glucose tolerance | – | Other: Oral glucose tolerance test (OGTT), Other: Isoglycemic intravenous glucose infusionSubjects with normal glucose tolerance and BMI>33 |
| Lean subjects with type 2 diabetes | – | Other: Oral glucose tolerance test (OGTT), Other: Isoglycemic intravenous glucose infusionPatients with type 2 diabetes and BM<25 |
| Lean subjects with normal glucose tolerance | – | Other: Oral glucose tolerance test (OGTT), Other: Isoglycemic intravenous glucose infusionSubjects with normal glucose tolerance and BM<25 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lean and obese patients with type 2 diabetes; and matched healthy control subjects.
Key inclusion criteria (3 listed)
- Diagnosed with type 2 diabetes for at least 3 months
- Normal blood hemoglobin
- Informed consent
Key exclusion criteria (3 listed)
- Liver disease
- Diabetic nephropathy
- Treatment with medication that can not be stopped for 12 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 test (OGTT) | Other | Lean subjects with normal glucose tolerance, Lean subjects with type 2 diabetes, Obese patients with type 2 diabetes, Obese subjects with normal glucose tolerance |
| Isoglycemic intravenous glucose infusion | Other | Lean subjects with normal glucose tolerance, Lean subjects with type 2 diabetes, Obese patients with type 2 diabetes, Obese subjects with normal glucose tolerance |
Primary outcome
Incretin effect
Time frame: 2 days
1 secondary outcome
Insulin resistance
Time frame: 2 days
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 13 Jan 2010.
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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.
Tina Vilsbøll, MD DMSc study chair
Department of Internal Medicine F, Gentofte Hospital, University of 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 Incretin Effect and Insulin Resistance, 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 3 inclusion and 3 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 13 Jan 2010. 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?
Incretin effect (time frame: 2 days). 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 13 Jan 2010.