ObesityPhase 4NCT00845559
The Effects of Exenatide on Post-Meal Sugar Peaks and Vascular Health in Obese/Pre-Diabetic Young Adults
A Phase 4 study testing Exenatide in people with Obesity and Insulin Resistance, run by Yale University.
Trial summary
The primary aim of this study is to evaluate the effect of exenatide on daily glycemic excursions obtained by continuous glucose monitoring system (CGMS). The CGMS summary parameters that we are most interested in include: The percent of glucose values above 140 mg/dl and/or AUC of glucose values above 140 mg/dl AUC… Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Impaired Glucose Tolerance
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Mar 2010
- Phase
- Phase 4
- 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 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Lean (BMI < 85%tile for age and sex matched normative data)
- Fasting insulin <15 mIU/m
- Fasting glucose <100 mg/dll
- Excellent general health, having no acute or chronic health problems and taking no current medications
- Age 13-25 yrs, in puberty (age matched with obese subjects)
- Girls who are sexually active must use adequate birth control methods (such as barrier method or oral contraception) and must have a negative pregnancy test
Who cannot join
- Raynaud's syndrome
- Pregnancy or breastfeeding mothers
- Cigarette smokers
- Psychiatric disorders
- History of substance abuse
- First degree relative with either T1DM or T2DM
- Presence of acanthosis nigricans
About this study
Official title: The Effects of Exenatide on Post-Prandial Glucose Excursions and Vascular Health in Obese/Pre-Diabetic Young Adults
The primary aim of this study is to evaluate the effect of exenatide on daily glycemic excursions obtained by continuous glucose monitoring system (CGMS). The CGMS summary parameters that we are most interested in include:
- The percent of glucose values above 140 mg/dl and/or AUC of glucose values above 140 mg/dl
- AUC of glucose values over 100 mg/dl during three days
- Maximal meal-related glucose excursions
- Three-day mean glucose (including low readings - below 100 mg/dl)
Read more
Secondary Study Endpoints:
Secondary endpoints will include:
- glucose tolerance status as assessed by OGTT
- Vascular function scores as assessed by PAT, FMD and step test.
- Biochemical markers of vascular health, including inflammatory markers, markers of oxidative stress and microalbuminuria.
- Changes in BMI
Read the detailed description
Obese insulin resistant adolescents with impaired glucose tolerance (IGT) or evidence of glucose excursions ≥ 140 mg/dl on CGMS will be enrolled in a two armed randomized, parallel group - open label study. There will also be a lean control group for baseline assessments only.
One arm will be exenatide the other arm will be no drug. Subjects will be stratified according to state of glucose tolerance. Stratification will also occur according to gender and family history of premature cardiovascular disease.
Obese adolescents age 16-25 years with a family history of type 2 diabetes, whom have completed or reached tanner IV stage of pubertal development and have normal or impaired oral glucose tolerance. Obese adolescents age 13-15 with a family history of type 2 diabetes, whom have completed or reached tanner III stage of pubertal development and have impaired oral glucose tolerance with a 2-hour glucose of 180-199 mg/dl will also be invited to participate. For cardiovascular assessment only age matched lean control subjects without diabetes will be recruited.
Obese subjects will have a baseline and post intervention oral glucose tolerance test (OGTT), screening labs (liver/kidney functions, lipid profile, thyroid function tests, CBC, metabolic and cardiovascular laboratory parameters -- such as inflammatory cytokines and pro-thrombotic factors), wear a CGMS for 3-days on 3 separate occasions (baseline, 2-month and 4-month), have a standardized snack once during each CGMS session, collect urine samples for microalbumin and have vascular tests (PAT, FMD and exercise step test) done at baseline and post intervention.
Subjects randomized to treatment will undergo a four month intervention with exenatide on the following dosing schedule: exenatide - 5 μg twice a day for 7 days, followed by exenatide 10 μg twice a day for the remainder of the four month intervention.
Lean Control Subjects:
As for obese subjects, lean subjects will be asked to bring in first morning voids for testing of microalbuminuria. They will also have endothelial function tests (PAT, FMD and step test) as well as CGMS placement. A set of screening labs will also be drawn (fasting glucose, insulin, thyroid function and lipid profile will be drawn). Furthermore blood will be collected for analysis of novel cardiovascular parameters (such as inflammatory cytokines and pro-thrombotic factors). However lean subjects will not have an OGTT done and will not be offered drug intervention. The endothelial function testing in the lean controls will serve as control data for the vascular function testing in the obese children. The CGMS data of the lean controls will allow us to better interpret changes in the post-meal excursions seen in obese children after exenatide intervention. Similar to obese subjects, lean subjects will be instructed to take a standardized snack in the afternoon prior to returning for CGMS removal. The snack will be provided for them to take home at the end of their CGMS placement visit and will include two pop-tarts and an orange soda. Lean control subjects will wear the CGMS for three days. At the end of the monitoring period the subject will return for their CGMS removal visit.
- Being tested
- Exenatide
- Keywords
- Childhood Obesity, Insulin resistance, Impaired Glucose Tolerance, Cardiovascular Disease, Type 2 Diabetes Mellitus, Continuous Glucose Monitoring (CGMS), Exenatide, Oral Glucose Tolerance Test
- Medical subject headings
- Obesity, Insulin Resistance, Glucose Intolerance, Cardiovascular Diseases, Pediatric Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
Subjects randomized to treatment will receive a four month supply of exenatide and will be taught how to administer subcutaneous injections with their exenatide pen and instructed on the following dosing schedule: exenatide - 5 μg twice a day for 7 days, followed by exenatide 10 μg twice a day for the remainder of the four month supply.
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | Subjects randomized to treatment will receive a four month supply of exenatide. Receives: Drug: Exenatide |
| No Treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether treatment with exenatide attenuates post-prandial glycemic excursions as assessed by oral glucose tolerance testing (OGTT) and continuous monitoring system (CGMS) technology.
Measured: OGTT (Pre- and post-intervention), CGMS (Pre-intervention, 2-months and post-intervention)
Secondary outcomes (2)
Cardiovascular risk parameters will be assessed via flow mediated vasodilation, peripheral arterial tonometry, a self-paced step test and biochemical markers of vascular health.
Measured: Pre- (baseline) and post- (4-months) intervention
Change in body mass index (BMI).
Measured: Pre-intervention, 2-month and post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Responsible party
- Sponsor
- Investigators
- Tania S Burgert, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845559
- Sponsor's protocol ID
- 0801003390
- Status last verified
- Dec 2012
- First submitted
- 16 Feb 2009
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exenatide on Post-Prandial Glucose Excursions and Vascular Health in Obese/Pre-Diabetic Young Adults
- ClinicalTrials.gov ID
- NCT00845559
- Acronym / sponsor ID
- 0801003390
- Keywords
- Childhood Obesity, Insulin resistance, Impaired Glucose Tolerance, Cardiovascular Disease, Type 2 Diabetes Mellitus, Continuous Glucose Monitoring (CGMS), Exenatide, Oral Glucose Tolerance Test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Study start
- Aug 2008
- Primary completion
- Mar 2010 (estimated)
- First posted
- 18 Feb 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 primary aim of this study is to evaluate the effect of exenatide on daily glycemic excursions obtained by continuous glucose monitoring system (CGMS). The CGMS summary parameters that we are most interested in include:
- The percent of glucose values above 140 mg/dl and/or AUC of glucose values above 140 mg/dl
- AUC of glucose values over 100 mg/dl during three days
- Maximal meal-related glucose excursions
- Three-day mean glucose (including low readings - below 100 mg/dl)
Secondary Study Endpoints:
Secondary endpoints will include:
- glucose tolerance status as assessed by OGTT
- Vascular function scores as assessed by PAT, FMD and step test.
- Biochemical markers of vascular health, including inflammatory markers, markers of oxidative stress and microalbuminuria.
- Changes in BMI
Detailed description
Obese insulin resistant adolescents with impaired glucose tolerance (IGT) or evidence of glucose excursions ≥ 140 mg/dl on CGMS will be enrolled in a two armed randomized, parallel group - open label study. There will also be a lean control group for baseline assessments only.
One arm will be exenatide the other arm will be no drug. Subjects will be stratified according to state of glucose tolerance. Stratification will also occur according to gender and family history of premature cardiovascular disease.
Obese adolescents age 16-25 years with a family history of type 2 diabetes, whom have completed or reached tanner IV stage of pubertal development and have normal or impaired oral glucose tolerance. Obese adolescents age 13-15 with a family history of type 2 diabetes, whom have completed or reached tanner III stage of pubertal development and have impaired oral glucose tolerance with a 2-hour glucose of 180-199 mg/dl will also be invited to participate. For cardiovascular assessment only age matched lean control subjects without diabetes will be recruited.
Obese subjects will have a baseline and post intervention oral glucose tolerance test (OGTT), screening labs (liver/kidney functions, lipid profile, thyroid function tests, CBC, metabolic and cardiovascular laboratory parameters -- such as inflammatory cytokines and pro-thrombotic factors), wear a CGMS for 3-days on 3 separate occasions (baseline, 2-month and 4-month), have a standardized snack once during each CGMS session, collect urine samples for microalbumin and have vascular tests (PAT, FMD and exercise step test) done at baseline and post intervention.
Subjects randomized to treatment will undergo a four month intervention with exenatide on the following dosing schedule: exenatide - 5 μg twice a day for 7 days, followed by exenatide 10 μg twice a day for the remainder of the four month intervention.
Lean Control Subjects:
As for obese subjects, lean subjects will be asked to bring in first morning voids for testing of microalbuminuria. They will also have endothelial function tests (PAT, FMD and step test) as well as CGMS placement. A set of screening labs will also be drawn (fasting glucose, insulin, thyroid function and lipid profile will be drawn). Furthermore blood will be collected for analysis of novel cardiovascular parameters (such as inflammatory cytokines and pro-thrombotic factors). However lean subjects will not have an OGTT done and will not be offered drug intervention. The endothelial function testing in the lean controls will serve as control data for the vascular function testing in the obese children. The CGMS data of the lean controls will allow us to better interpret changes in the post-meal excursions seen in obese children after exenatide intervention. Similar to obese subjects, lean subjects will be instructed to take a standardized snack in the afternoon prior to returning for CGMS removal. The snack will be provided for them to take home at the end of their CGMS placement visit and will include two pop-tarts and an orange soda. Lean control subjects will wear the CGMS for three days. At the end of the monitoring period the subject will return for their CGMS removal visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: ExenatideSubjects randomized to treatment will receive a four month supply of exenatide. |
| No Treatment | No intervention | – |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Lean (BMI < 85%tile for age and sex matched normative data)
- Fasting insulin <15 mIU/m
- Fasting glucose <100 mg/dll
- Excellent general health, having no acute or chronic health problems and taking no current medications
- Age 13-25 yrs, in puberty (age matched with obese subjects)
Key exclusion criteria (7 listed)
- Raynaud's syndrome
- Pregnancy or breastfeeding mothers
- Cigarette smokers
- Psychiatric disorders
- History of substance abuse
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 |
|---|---|---|
| ExenatideAlso: ByettaSubjects randomized to treatment will receive a four month supply of exenatide and will be taught how to administer subcutaneous injections with their exenatide pen and instructed on the following dosing schedule: exenatide - 5 μg twice a day for 7 days, followed by exenatide 10 μg twice a day for the remainder of the four month supply. | Drug | Exenatide |
Primary outcome
Whether treatment with exenatide attenuates post-prandial glycemic excursions as assessed by oral glucose tolerance testing (OGTT) and continuous monitoring system (CGMS) technology.
Time frame: OGTT (Pre- and post-intervention), CGMS (Pre-intervention, 2-months and post-intervention)
2 secondary outcomes
Cardiovascular risk parameters will be assessed via flow mediated vasodilation, peripheral arterial tonometry, a self-paced step test and biochemical markers of vascular health.
Time frame: Pre- (baseline) and post- (4-months) intervention
Change in body mass index (BMI).
Time frame: Pre-intervention, 2-month and post-intervention.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
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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.
Tania S Burgert, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exenatide in people with Obesity and Insulin Resistance, run by Yale University.
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 7 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: withdrawn, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Whether treatment with exenatide attenuates post-prandial glycemic excursions as assessed by oral glucose tolerance testing (OGTT) and continuous monitoring system (CGMS) technology. (time frame: OGTT (Pre- and post-intervention), CGMS (Pre-intervention, 2-months and post-intervention)). 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 11 Dec 2012.