Obesity, Morbid Clinical Trial
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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