Trial · Interventional

CompletedPhase 2Results postedRegistry data

Exenatide in Extreme Pediatric Obesity

NCTNCT01237197Other id1009M88952

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 26 participants (actual)
Sponsor: University of Minnesota · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Oct 2010
Primary completion: May 2012
Completion: Oct 2012
First posted: 9 Nov 2010 (estimated)
Last update posted: 12 Sept 2014 (estimated)
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2010201120122013

Ph 2
Exenatide in Extreme Pediatric Obesity
NCT01237197
Oct 2010 to Oct 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

ExenatideDrug
PlaceboDrug

Arms2

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)
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent Change From Baseline in Body Mass Index at 3-months
Time frame · Baseline and 3-months
Registry description
As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 3-months

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

Group	Value (percentage of change in BMI)	Spread
Exenatide	-2.9	1.8
Placebo Injection	-0.15	3.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
ExenatideExenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months) Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study.	–	0 / 13	12 / 13
Placebo InjectionPlacebo 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. Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study.	–	0 / 13	12 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedKelly 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. PMID 23380890

Eligibility

Who could join, as posted.

Sex: All
Age: from 12 Years up to 19 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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