Exenatide in Extreme Pediatric Obesity

This study has been completed.
Sponsor:
Collaborator:
Children's Hospitals and Clinics of Minnesota
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01237197
First received: November 1, 2010
Last updated: September 4, 2014
Last verified: September 2014

November 1, 2010
September 4, 2014
October 2010
May 2012   (final data collection date for primary outcome measure)
Percent Change From Baseline in Body Mass Index at 3-months [ Time Frame: Baseline and 3-months ] [ Designated as safety issue: No ]
As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.
Body Mass Index [ Time Frame: 3-months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01237197 on ClinicalTrials.gov Archive Site
Not Provided
  • Systolic Blood Pressure [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • Fasting Insulin [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • High Density Lipoprotein Cholesterol [ Time Frame: 3-months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Exenatide in Extreme Pediatric Obesity
Exenatide in Extreme Pediatric Obesity

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Drug: Exenatide
    Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.
    Other Name: Byetta
  • Drug: Placebo
    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).
    Other Name: Sugar pill
  • Experimental: Exenatide, then Open-Label Exenatide
    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)
    Intervention: Drug: Exenatide
  • Placebo Comparator: Placebo, then Open Label Exenatide
    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.
    Interventions:
    • Drug: Exenatide
    • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
October 2012
May 2012   (final data collection date for primary outcome measure)

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)
Both
12 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01237197
1009M88952
Yes
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Children's Hospitals and Clinics of Minnesota
Principal Investigator: Aaron S. Kelly, Ph.D. University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP