NA · Exenatide

NCT01444898 trial results

Effects of Exenatide on Obesity and Appetite in Overweight Patients With Prader-Willi Syndrome

Participants: 10
Status: completed
Completed: 2013-12
Sponsor: Children's Hospital Los Angeles

As posted on ClinicalTrials.gov (NCT01444898), updated at source Sep 29, 2016. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01444898 measured first

Change in Weightkg · 6 months · mean

Exenatiden=10
-.5(.9)

% Change in Body Mass Index (BMI)% change in BMI · 6 months · mean

Exenatiden=10
1.3(2)

Change in BMI Z-Scoreunits on a scale · 6 months · mean

Exenatiden=10
.1(.4)

Change in HbA1c (%)percentage · 6 months · mean

Exenatiden=10
-.3(.2)

Change in Insulin Levelsu/U ml^-1 · 6 months · mean

Exenatiden=10
3(.5)

Change in Leptinng ml^-1 · 6 months · mean

Exenatiden=10
-7.4(3.8)

Change in Acy Ghrpg ml^-1 · 6 months · mean

Exenatiden=10
263(99.5)

Change in Pancreatic Peptide (PP)pg ml^-1 · 6 months · mean

Exenatiden=10
15(6)

Appetite Scoresunits on a scale · 6 months · mean

Measure	Exenatiden=10
Total Appetite Score Baseline	32.2(8.7)
Total Appetite Score 6 month	25.4(7.2)
Behavior Score Baseline	14.5(4.9)
Behavior Score 6 months	10.6(3.8)
Drive Score Baseline	12.6(3.1)
Drive Score 6 months	10.4(2.7)
Severity Score Baseline	5.1(1.5)
Severity Score 6 months	4.4(2.2)

Side effects by arm

Side effects in NCT01444898

Percent of participants affected. The most common events the registry lists.

Event	Exenatide
Any serious event	0%
abdominal discomfort with diarrhea	20%

The trial

How NCT01444898 was run

Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a major source of morbidity and mortality in this population. It can lead to sleep apnea, cor pulmonale, diabetes mellitus, and atherosclerosis. PWS has distinct characteristics that set it apart from other forms of obesity including insatiable appetite and food-seeking behavior which can be disruptive to home and school activities, and can cause severe social and psychological turmoil within families. PWS is also associated with unique hormonal abnormalities, most notably hyperghrelinemia. Ghrelin is a gut hormone produced in the stomach that stimulates food intake during a fast. It is hypothesized that the extremely high ghrelin levels in patients with PWS may cause or contribute to their insatiable appetite. Exenatide, a medication used in the treatment of type 2 diabetes mellitus in adults, appears to suppress ghrelin levels and cause weight loss. It was designed to mimic glucagon-like peptide 1 (GLP-1), an incretin hormone that stimulates insulin secretion and delays gastric emptying, among other effects. In the present study, the investigators will investigate the effects of a 6 month trial of exenatide in overweight adolescents with PWS. The investigators will quantify the changes in weight and body composition, as well as subjective measures of appetite, and concentrations of appetite-associated hormones. The investigators hypothesize that exenatide will improve weight, body composition, appetite, and plasma ghrelin levels during the treatment period.

Exenatide: All subjects enrolled in this study will be given Exenatide for 6 months. Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months).

Who could join the trial

Inclusion Criteria: * Diagnosis of Prader Willi Syndrome confirmed by genetic testing (DNA methylation or FISH) * Ages 13-20 years * body mass index (BMI) \> 85th percentile for age and gender Exclusion Criteria: * Is currently using or has previously used a glucagon-like peptide-1 (GLP-1) agonist * History of pancreatitis, or renal failure * History of familial pancreatitis * Amylase, or lipase levels \> 2.5 times the upper limit of normal any time in the previous 2 years * Creatinine clearance \< 30 mL/min * Other syndromic diagnoses * gastrointestinal (GI) or renal illness in the 1 month prior to entering study * Inability to take study drug * Pregnancy * Initiation of growth hormone (GH), estrogen, or testosterone or change \> 25% of dose/kg/day during the 6 months prior to starting study * Non-English speaking

Published papers

Papers from NCT01444898

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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