Exenatide in Extreme Pediatric Obesity
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Body mass index > or = 1.2 times the 95th percentile (based on gender and age) or Body mass index > or = 35 kg/m2
- 12-19 years old
Exclusion Criteria:
- Type 1 or 2 diabetes mellitus
- Previous (within 3-months) or current use of weight loss medication (patients may undergo washout)
- Previous bariatric surgery
- Recent initiation (within 1-month) of anti-hypertensive or lipid medication
- Previous (within 1-month) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout)
- Major psychiatric disorder
- Pregnant or planning to become pregnant
- Tobacco use
- Liver/renal dysfunction
- History of pancreatitis
- Obesity associated with genetic disorder
- Hyperthyroidism or uncontrolled hypothyroidism
- Uncontrolled hypertriglyceridemia (=300 mg/dL)
- Current eating disorder
- Previous (within 3-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)
Sites / Locations
- University of Minnesota
- Children's Hospitals and Clinics of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exenatide, then Open-Label Exenatide
Placebo, then Open Label Exenatide
Arm Description
Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Body Mass Index at 3-months
As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.
Secondary Outcome Measures
Full Information
NCT ID
NCT01237197
First Posted
November 1, 2010
Last Updated
September 4, 2014
Sponsor
University of Minnesota
Collaborators
Children's Hospitals and Clinics of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01237197
Brief Title
Exenatide in Extreme Pediatric Obesity
Official Title
Exenatide in Extreme Pediatric Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Children's Hospitals and Clinics of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM). Obesity tracks strongly into adulthood and interventions early in life may reduce risk for developing cardiovascular disease and type 2 diabetes. Few drug therapies for weight loss have been evaluated in adolescents. Since exenatide is associated with weight loss and improves risk factors for cardiovascular disease and type 2 diabetes in adults, it may be useful in extremely obese youth. Our primary objective in this study is to generate preliminary data on the ability of exenatide to reduce body mass index (BMI) and improve risk factors for cardiovascular disease and type 2 diabetes in 26 extremely obese adolescents (age 12-19 years) in a three-month, randomized, double-blind, placebo-controlled pilot clinical trial. GLP-1 therapy has never been evaluated as a treatment for pediatric obesity and is an innovative approach to a challenging and significant health care problem.
Detailed Description
26 (approximately 13 per site) extremely obese (Body mass index [BMI] > or = 1.2 times the 95th percentile or BMI > or = 35 kg/m2) adolescents (age 12-19 years old) will be enrolled in a six-month study consisting of a three-month, randomized, double-blind (participants and investigators), placebo-controlled pilot clinical trial phase followed by a three-month open-label extension during which all participants will receive exenatide. For the initial three-month phase, participants will be equally (by site) and randomly assigned to one of two groups: 1) exenatide plus lifestyle modification, or 2) placebo plus lifestyle modification. Following baseline testing, subjects will be randomly assigned to study group. Participants will return at one-month for titration and assessment of safety (blood draw and adverse event assessment) and injection/lifestyle modification compliance and at three-months for reassessment of baseline variables and injection/lifestyle modification compliance and allocation to study drug for the three-month open-label extension. Participants will return at four-months for assessment of safety (blood draw and adverse event assessment) and injection/lifestyle modification compliance and at six-months for reassessment of baseline variables and injection/lifestyle modification compliance.
All subjects, regardless of group assignment, will participate in the clinical lifestyle modification program offered through either the University of Minnesota or Children's Hospitals and Clinics weight management programs. Participants and their families receive regular (approximately bi-monthly) face-to-face and/or phone behavioral-, dietary-, and physical activity-counseling from a multi-disciplinary team of health care professionals including physicians, dieticians, registered nurses, psychologists, and exercise physiologists.
Screening will include review of medical records for previous clinical and laboratory data. The following measures will be collected at baseline, 3 months, and 6 months. Subject will be asked to fast for a minimum of 12 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exenatide, then Open-Label Exenatide
Arm Type
Experimental
Arm Description
Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
Arm Title
Placebo, then Open Label Exenatide
Arm Type
Placebo Comparator
Arm Description
Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Byetta
Intervention Description
Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Participants were randomized to a placebo injection for the first three months, then given open-label Exenatide for the remaining three months (Initiated at 5 mcg, twice per day, delivered by subcutaneous injection. After 1 month, exenatide was uptitrated to 10 mcg, twice per day for the remaining 2 months of the drug treatment phase).
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Body Mass Index at 3-months
Description
As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.
Time Frame
Baseline and 3-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index > or = 1.2 times the 95th percentile (based on gender and age) or Body mass index > or = 35 kg/m2
12-19 years old
Exclusion Criteria:
Type 1 or 2 diabetes mellitus
Previous (within 3-months) or current use of weight loss medication (patients may undergo washout)
Previous bariatric surgery
Recent initiation (within 1-month) of anti-hypertensive or lipid medication
Previous (within 1-month) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout)
Major psychiatric disorder
Pregnant or planning to become pregnant
Tobacco use
Liver/renal dysfunction
History of pancreatitis
Obesity associated with genetic disorder
Hyperthyroidism or uncontrolled hypothyroidism
Uncontrolled hypertriglyceridemia (=300 mg/dL)
Current eating disorder
Previous (within 3-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron S. Kelly, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23380890
Citation
Kelly AS, Rudser KD, Nathan BM, Fox CK, Metzig AM, Coombes BJ, Fitch AK, Bomberg EM, Abuzzahab MJ. The effect of glucagon-like peptide-1 receptor agonist therapy on body mass index in adolescents with severe obesity: a randomized, placebo-controlled, clinical trial. JAMA Pediatr. 2013 Apr;167(4):355-60. doi: 10.1001/jamapediatrics.2013.1045.
Results Reference
derived
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Exenatide in Extreme Pediatric Obesity
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