Exenatide in Extreme Pediatric Obesity

• ClinicalTrials.gov Identifier: NCT01237197
• Recruitment Status: Completed
• First Posted: November 9, 2010
• Results First Posted: September 12, 2014
• Last Update Posted: September 12, 2014
• Sponsor: University of Minnesota
• Collaborator: Children's Hospitals and Clinics of Minnesota
• Information provided by (Responsible Party): University of Minnesota

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Obesity
• Interventions: Drug: Exenatide; Drug: Placebo
• Enrollment: 26

Participant Flow

Recruitment Details	Participants were recruited from the University of Minnesota, Amplatz Children's Hospital Pediatric Weight Management Clinic in Minneapolis or the McNeely Pediatric Diabetes Center and Endocrinology Clinic, Children's Hospitals and Clinics of Minnesota in St Paul.
Pre-assignment Details

Arm/Group Title	Exenatide	Placebo Injection
Arm/Group 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) Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.	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. Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.
Period Title: Randomization Period
Started	13	13
Completed	12	10
Not Completed	1	3
Period Title: Open Label Period
Started	12	10
Completed	12	10
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Exenatide	Placebo Injection	Total
Arm/Group 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) Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.	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. Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.	Total of all reporting groups
Overall Number of Baseline Participants		13	13	26
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants	13 participants	26 participants
	<=18 years	13 100.0%	13 100.0%	26 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	13 participants	13 participants	26 participants
		14.9 (1.76)	15.5 (1.88)	15.2 (1.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants	13 participants	26 participants
	Female	8 61.5%	8 61.5%	16 61.5%
	Male	5 38.5%	5 38.5%	10 38.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	13 participants	13 participants	26 participants
		13	13	26

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Placebo Injection
Arm/Group Description:	Exenatide 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.	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. 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.
Overall Number of Participants Analyzed	12	10
Mean (Standard Deviation); Unit of Measure: percentage of change in BMI
	-2.9 (1.8)	-0.15 (3.2)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Exenatide		Placebo Injection
Arm/Group Description	Exenatide 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.		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. 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.
All-Cause Mortality
	Exenatide		Placebo Injection
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Exenatide		Placebo Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0.00%)		0/13 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Exenatide		Placebo Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/13 (92.31%)		12/13 (92.31%)
Gastrointestinal disorders
Nausea *	8/13 (61.54%)	13	4/13 (30.77%)	4
Vomiting *	4/13 (30.77%)	5	1/13 (7.69%)	1
Diarrhea *	1/13 (7.69%)	1	4/13 (30.77%)	4
Nervous system disorders
Headache *	3/13 (23.08%)	4	6/13 (46.15%)	6
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Aaron S. Kelly, Ph.D.
• Organization: University of Minnesota
• Phone: 612-626-3492
• EMail: kelly105@umn.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01237197
• Other Study ID Numbers: 1009M88952
• First Submitted: November 1, 2010
• First Posted: November 9, 2010
• Results First Submitted: September 10, 2013
• Results First Posted: September 12, 2014
• Last Update Posted: September 12, 2014