Hypothalamic ObesityPhase 1/2NCT01061775
Effects of Exenatide on Hypothalamic Obesity
A Phase 1/2 study testing Exenatide in people with Hypothalamic Obesity, run by Children's Hospitals and Clinics of Minnesota at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Hypothalamic Obesity
- What is being tested?
- Exenatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to 15 Mar 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- >/=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
Who cannot join
- < 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
Show all 10Show fewer
- <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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospitals & Clincis of Minnesota
Saint Paul, Minnesota, 55102
About this study
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.
Read the detailed description
Hypothalamic obesity is when individuals suffer from acute weight gain after brain tumor treatment, involving secondary damage to the ventromedial nucleus of the hypothalamus, which may lead to obesity. The weight gain is uncontrolled and not receptive to diet and exercise interventions. The rate of long-term obesity in children diagnosed with craniopharyngioma can be as high as 50%. Exenatide, a drug indicated for diabetes, is an incretin mimicking agent that mimics the enhancement of glucose-dependent insulin secretion and several other antihyperglycemic actions of incretins has resulted in weight loss when given to diabetics. Exenatide shows potential to benefit patients suffering from hypothalamic obesity by slowing gastric emptying and therefore reducing food intake. Also increasing the glucagon-like peptide 1 (GLP-1) circulation, decreased due to obesity, at the already compromised GLP-1 receptor site of the hypothalamus could potentially help with regulation of appetite.
- Conditions
- Hypothalamic Obesity
- Being tested
- Exenatide
- Keywords
- Hypothalamic Obesity, Exenatide, Byetta, Craniopharyngioma
- Medical subject headings
- Sexual Infantilism, Craniopharyngioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | 5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks. Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Change
BMI was collected at baseline and 24 weeks
Measured: 24 weeks
Waist to Height Ratio (WHtR)
Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks
Measured: 24 weeks
Secondary outcomes (2)
Childhood Eating Behavior Questionnaire (CEBQ)
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.
Measured: 24 weeks
Calorie Intake Based on 3-day Diet Records
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypothalamic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Responsible party
- Sponsor
- Investigators
- M. Jennifer Abuzzahab, MD, Principal investigator, Children's Hospitals & Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061775
- Sponsor's protocol ID
- 0903-028
- Status last verified
- Sep 2019
- First submitted
- 2 Feb 2010
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: We do not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exenatide on Hypothalamic Obesity
- ClinicalTrials.gov ID
- NCT01061775
- Acronym / sponsor ID
- 0903-028
- Conditions
- Hypothalamic Obesity
- Keywords
- Hypothalamic Obesity, Exenatide, Byetta, Craniopharyngioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Posted 21 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothalamic obesity is when individuals suffer from acute weight gain after brain tumor treatment, involving secondary damage to the ventromedial nucleus of the hypothalamus, which may lead to obesity. The weight gain is uncontrolled and not receptive to diet and exercise interventions. The rate of long-term obesity in children diagnosed with craniopharyngioma can be as high as 50%. Exenatide, a drug indicated for diabetes, is an incretin mimicking agent that mimics the enhancement of glucose-dependent insulin secretion and several other antihyperglycemic actions of incretins has resulted in weight loss when given to diabetics. Exenatide shows potential to benefit patients suffering from hypothalamic obesity by slowing gastric emptying and therefore reducing food intake. Also increasing the glucagon-like peptide 1 (GLP-1) circulation, decreased due to obesity, at the already compromised GLP-1 receptor site of the hypothalamus could potentially help with regulation of appetite.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: Exenatide5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- >/=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
Key exclusion criteria (10 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: Byetta5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks. | Drug | Exenatide |
Primary outcome
BMI Change
Time frame: 24 weeks
BMI was collected at baseline and 24 weeks
Waist to Height Ratio (WHtR)
Time frame: 24 weeks
Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks
2 secondary outcomes
Childhood Eating Behavior Questionnaire (CEBQ)
Time frame: 24 weeks
Calorie Intake Based on 3-day Diet Records
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hospital websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data.
Related trials for Hypothalamic Obesity
Recruiting
Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
Cushing Syndrome, Adrenal Insufficiency
Active, not recruitingPhase 2
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
Hypothalamic Obesity, Hypothalamic Tumor
Active, not recruitingPhase 1/2
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Hypothalamic Obesity, Prader-Willi Syndrome
Not yet recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
Not yet recruitingPhase 3
SEMAFORCRANIO : Multicenter, Double-blind, Parallel, Randomized Controlled Trial of the Efficacy of Semaglutide in Hypothalamic Obesity Secondary to Craniopharyngioma in Children Aged 12 to 17 Years
Craniopharyngioma, Child
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Jennifer Abuzzahab, MD principal investigator
Children's Hospitals & Clinics of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exenatide in people with Hypothalamic Obesity, run by Children's Hospitals and Clinics of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI Change (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.