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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

exenatide

Drug

Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.

Other names: Byetta

Placebo

Drug

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 names: Sugar pill

Primary outcomes

Percent Change From Baseline in Body Mass Index at 3-months

Time frame: Baseline and 3-months

As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

Children's Hospitals and Clinics of Minnesota

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Nov 9, 2010
Registry last updated: Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed