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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Effects of Exenatide on Hypothalamic Obesity

NCTNCT01061775 (opens ClinicalTrials.gov in a new tab)Other id0903-028
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Overview

Status
Completed
Phase
Phase 1/2
Enrollment
19 participants (actual)
Sponsor
Children's Hospitals and Clinics of Minnesota · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jan 2010
Primary completion
Jul 2013
Completion
15 Mar 2019
First posted
3 Feb 2010 (estimated)
Last update posted
8 Oct 2019
Conditions
Hypothalamic Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020122014201620182020
  1. Ph 1/2

    Effects of Exenatide on Hypothalamic Obesity

    NCT01061775

    Jan 2010 to 15 Mar 2019

Registry summary

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

The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index) of children treated for craniopharyngioma that have developed hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that Exenatide given to hypothalamic obese children for 6 months will reduce their body mass index significantly from baseline.

Interventions

  • ExenatideDrug

Arms1

  • Experimental

    Exenatide

    5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. BMI Change

    Time frame · 24 weeks

    Registry description

    BMI was collected at baseline and 24 weeks

  2. Waist to Height Ratio (WHtR)

    Time frame · 24 weeks

    Registry description

    Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks

Secondary outcomes(2)

  1. Childhood Eating Behavior Questionnaire (CEBQ)

    Time frame · 24 weeks

    Registry description

    The Child Eating Behaviour Questionnaire (CEBQ) was designed as parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. We utilized the CEBQ as a self-report measure during this study; it has not been validated for such use. For the purposes of this study, we looked at the Satiety Responsiveness Subscale Scores (5 questions; total scores could range from 5-25 with lower scores denoting a lower level of satiety). The results reported show the change between baseline and week 24 scores.

  2. Calorie Intake Based on 3-day Diet Records

    Time frame · 24 weeks

    Registry description

    Dietary data were collected via 3-day diet records (Crawford et al. 1994) twice during the study, at baseline and week 24. Three-day diet records were collected on consecutive days including one weekend day. A registered dietitian (RD) instructed subjects on dietary data collection at baseline appointment. Depending on the age and capacity of the subject, the patient, parent or a collaboration of both recorded dietary intake. A RD entered dietary data into Nutritionist Pro software (First DataBank, SanBruno, CA) and the mean difference was analyzed.

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· 24 weeks

BMI Change

GroupValue (kg/m^2)
Exenatide-0.77
Primary outcomeMean· 24 weeks

Waist to Height Ratio (WHtR)

GroupValue (percentage)Spread
Exenatide-2.060.08
Secondary and other outcome results(2)
Secondary outcomeMean· 24 weeks

Childhood Eating Behavior Questionnaire (CEBQ)

GroupValue (units on a scale)
Exenatide14
Secondary outcomeMean· 24 weeks

Calorie Intake Based on 3-day Diet Records

GroupValue (kcals)
Exenatide406.700

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ExenatideExenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.–2 / 1917 / 19

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.

Eligibility

Who could join, as posted.

Sex
All
Age
from 10 Years up to 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * \>/=6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors * 10-21 years old * Age-and sex-adjusted BMI \>/=95% * Parent sign consent and patient sign assent Exclusion Criteria: * \< 6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors * Pregnant or breastfeeding, or those women who plan to get pregnant * Renal impairment * Gastroparesis * Pancreatitis * Diabetes * \<1 month post initiation of Metformin treatment * Prescription or over-the-counter weight loss medications within 3 months of screening * Are actively participating in, or have participated in a formal weight loss program within the last 3 months * Have had bariatric surgery

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