Obesity, MorbidPhase 2NCT00886626
GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children
A Phase 2 study testing Exenatide in people with Obesity, Morbid, run by University of Minnesota at 1 site in United States.
Trial summary
The prevalence of severely obese children is on the rise. Behavioral therapies for weight loss are successful in some, but others need more aggressive approaches such as drug therapy. Read more about this study
- Who is it for?
- Ages 8 to 19 years
- Conditions the study is for
- Obesity, Morbid
- 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8-19 years old
- Subject able to give assent, and parent/guardian capable of giving consent on behalf of the child
- Body mass index (BMI) ≥ 99th percentile (based on gender and age)
Who cannot join
- Type 1 or 2 diabetes mellitus
- Initiation of a new drug therapy within the past 30 days prior to the screening visit
- BMI ≥ 55
- History of weight loss surgery
- Obesity from a genetic cause (e.g., Prader-Willi)
- Central nervous system injury or severe neurological impairment
Show all 11Show fewer
- Known systolic or diastolic dysfunction or heart failure
- Females who are currently pregnant or planning to become pregnant
- Liver enzymes > 2.5 times upper limit of normal
- Severe renal impairment (defined as creatinine clearance <30 mL/min)
- Gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children: A Randomized, Controlled, Pilot Study
The prevalence of severely obese children is on the rise. Behavioral therapies for weight loss are successful in some, but others need more aggressive approaches such as drug therapy. In addition, up to 25% of severely obese children have impaired glucose tolerance (IGT), which places them at significantly elevated risk of developing type 2 diabetes mellitus and cardiovascular disease. Although various drug therapies for weight loss and IGT have been explored in adults, few have been evaluated in children.
Recently, a new drug class has emerged that targets deficiencies of GLP-1. One of the main glycemic mechanisms of action of the GLP-1 agonists such as exenatide is to enhance glucose disposal in the postprandial setting and improve glucose tolerance. In addition, exenatide can induce weight loss by decreasing appetite and slowing gastric motility.
Read the detailed description
This will be a randomized, open-label, controlled, crossover clinical trial in 12 patients. All patients will receive exenatide and undergo the control phase. Following baseline testing, participants will be randomly assigned to treatment order: therapy (exenatide) or control (lifestyle modification). Half (n = 6) will receive exenatide first (3-months) then cross over to control (no drug therapy for 3-months). Half (n = 6) will be assigned to control first (3-months) then cross over to exenatide (3-months). All efforts will be made to stratify randomization based on gender of the participants. Treatment and control conditions will be three months each. Because of the route of administration of exenatide (subcutaneous injection), placebo will not be utilized for the control phase of the study.
Participants in this study will engage in background intensive lifestyle modification offered by the University of Minnesota Pediatric Weight Management Clinic for the entire study, even during the active drug treatment phase. Intensive lifestyle modification will be purely clinical in nature in which children and their families receive continuing counseling from a team of trained professionals including physicians, dieticians, and psychologists to reduce weight by making healthier eating choices and increasing physical activity.
The screening visit will take place in the Pediatric Weight Management Clinic and will include a complete medical history and physical examination. Screening will include review of medical records for previous clinical and laboratory data (including clinically-ordered glucose tolerance test results). All research testing will take place in the University of Minnesota General Clinical Research Center (GCRC). Subjects will undergo testing at the following intervals: baseline, immediately after the first 3-month phase (whether exenatide or control), and immediately after the second 3- month phase (whether exenatide or control). The following measures will be collected after the subject has been fasting for at least twelve hours:
- Height, weight, body mass index, waist and hip circumference
- Fat and lean mass (dual energy x-ray absorptiometry: DXA)
- Tanner stage determination (performed during screening physical exam or may be obtained from medical chart)
- Fasting lipid profile (total-, LDL-, and HDL-cholesterol, triglycerides)
- Systolic and diastolic blood pressure
- Oral glucose tolerance test (glucose and insulin measured every 30 minutes for 2 hours)
- Endothelial function (digital reactive hyperemia: EndoPAT 2000, Itamar Medical) - in addition to the baseline measure, endothelial function testing will occur at hours one and two of the oral glucose tolerance test
- Frozen plasma for storage - in addition to the baseline blood draw, blood for endothelial biomarkers will be obtained at hours one and two of the oral glucose tolerance test
- Arterial stiffness (pulse wave velocity; augmentation index: Sphygmocor, AtCor Medical)
- Frozen plasma for pharmacokinetic determination of exenatide in children
- Conditions
- Obesity, Morbid
- Being tested
- Exenatide
- Keywords
- Obesity, Impaired Glucose Tolerance, Children
- Medical subject headings
- Obesity, Morbid, Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
Exenatide, subcutaneous injection, 10 mcg, twice per day
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | Exenatide Receives: Drug: Exenatide |
| Control | No intervention | Control - no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI)
Change in body mass index (BMI) over three months
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron S. Kelly, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886626
- Sponsor's protocol ID
- 0902M59181
- Status last verified
- Oct 2012
- First submitted
- 22 Apr 2009
- Last updated
- 29 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kelly AS, Metzig AM, Rudser KD, Fitch AK, Fox CK, Nathan BM, Deering MM, Schwartz BL, Abuzzahab MJ, Gandrud LM, Moran A, Billington CJ, Schwarzenberg SJ. Exenatide as a weight-loss therapy in extreme pediatric obesity: a randomized, controlled pilot study. Obesity (Silver Spring). 2012 Feb;20(2):364-70. doi: 10.1038/oby.2011.337. Epub 2011 Nov 10.
PubMed 22076596
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children: A Randomized, Controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT00886626
- Acronym / sponsor ID
- 0902M59181
- Conditions
- Obesity, Morbid
- Keywords
- Obesity, Impaired Glucose Tolerance, Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 17 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of severely obese children is on the rise. Behavioral therapies for weight loss are successful in some, but others need more aggressive approaches such as drug therapy. In addition, up to 25% of severely obese children have impaired glucose tolerance (IGT), which places them at significantly elevated risk of developing type 2 diabetes mellitus and cardiovascular disease. Although various drug therapies for weight loss and IGT have been explored in adults, few have been evaluated in children.
Recently, a new drug class has emerged that targets deficiencies of GLP-1. One of the main glycemic mechanisms of action of the GLP-1 agonists such as exenatide is to enhance glucose disposal in the postprandial setting and improve glucose tolerance. In addition, exenatide can induce weight loss by decreasing appetite and slowing gastric motility.
Detailed description
This will be a randomized, open-label, controlled, crossover clinical trial in 12 patients. All patients will receive exenatide and undergo the control phase. Following baseline testing, participants will be randomly assigned to treatment order: therapy (exenatide) or control (lifestyle modification). Half (n = 6) will receive exenatide first (3-months) then cross over to control (no drug therapy for 3-months). Half (n = 6) will be assigned to control first (3-months) then cross over to exenatide (3-months). All efforts will be made to stratify randomization based on gender of the participants. Treatment and control conditions will be three months each. Because of the route of administration of exenatide (subcutaneous injection), placebo will not be utilized for the control phase of the study.
Participants in this study will engage in background intensive lifestyle modification offered by the University of Minnesota Pediatric Weight Management Clinic for the entire study, even during the active drug treatment phase. Intensive lifestyle modification will be purely clinical in nature in which children and their families receive continuing counseling from a team of trained professionals including physicians, dieticians, and psychologists to reduce weight by making healthier eating choices and increasing physical activity.
The screening visit will take place in the Pediatric Weight Management Clinic and will include a complete medical history and physical examination. Screening will include review of medical records for previous clinical and laboratory data (including clinically-ordered glucose tolerance test results). All research testing will take place in the University of Minnesota General Clinical Research Center (GCRC). Subjects will undergo testing at the following intervals: baseline, immediately after the first 3-month phase (whether exenatide or control), and immediately after the second 3- month phase (whether exenatide or control). The following measures will be collected after the subject has been fasting for at least twelve hours:
- Height, weight, body mass index, waist and hip circumference
- Fat and lean mass (dual energy x-ray absorptiometry: DXA)
- Tanner stage determination (performed during screening physical exam or may be obtained from medical chart)
- Fasting lipid profile (total-, LDL-, and HDL-cholesterol, triglycerides)
- Systolic and diastolic blood pressure
- Oral glucose tolerance test (glucose and insulin measured every 30 minutes for 2 hours)
- Endothelial function (digital reactive hyperemia: EndoPAT 2000, Itamar Medical) - in addition to the baseline measure, endothelial function testing will occur at hours one and two of the oral glucose tolerance test
- Frozen plasma for storage - in addition to the baseline blood draw, blood for endothelial biomarkers will be obtained at hours one and two of the oral glucose tolerance test
- Arterial stiffness (pulse wave velocity; augmentation index: Sphygmocor, AtCor Medical)
- Frozen plasma for pharmacokinetic determination of exenatide in children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: ExenatideExenatide |
| Control | No intervention | –Control - no intervention |
Who may qualify
- Ages
- 8 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 8-19 years old
- Subject able to give assent, and parent/guardian capable of giving consent on behalf of the child
- Body mass index (BMI) ≥ 99th percentile (based on gender and age)
Key exclusion criteria (11 listed)
- Type 1 or 2 diabetes mellitus
- Initiation of a new drug therapy within the past 30 days prior to the screening visit
- BMI ≥ 55
- History of weight loss surgery
- Obesity from a genetic cause (e.g., Prader-Willi)
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: ByettaExenatide, subcutaneous injection, 10 mcg, twice per day | Drug | Exenatide |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: 3-month
Change in body mass index (BMI) over three months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22076596Kelly AS, Metzig AM, Rudser KD, Fitch AK, Fox CK, Nathan BM, Deering MM, Schwartz BL, Abuzzahab MJ, Gandrud LM, Moran A, Billington CJ, Schwarzenberg SJ. Exenatide as a weight-loss therapy in extreme pediatric obesity: a randomized, controlled pilot study. Obesity (Silver Spring). 2012 Feb;20(2):364-70. doi: 10.1038/oby.2011.337. Epub 2011 Nov 10.
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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.
Aaron S. Kelly, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exenatide in people with Obesity, Morbid, run by University of Minnesota at 1 site in United States.
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 11 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 29 Oct 2012. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Body Mass Index (BMI) (time frame: 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00886626, which also lists 1 linked publication.
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 29 Oct 2012.