ObesityPhase 2NCT01484873
Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
A Phase 2 study testing Exenatide in people with Obesity and Overweight, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obesity, Overweight, Craniopharyngioma
- What is being tested?
- Exenatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Mar 2015
- Phase
- Phase 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 40 years old
- History of craniopharyngioma or other lesion in the hypothalamic region
- Greater than 6 months post-treatment, including chemotherapy, surgery or radiation
- BMI >30 mg/m2
- Females must be post-menopausal, surgically sterile or using effective birth control for at least 12 weeks
Who cannot join
- HgbA1C >7%
- Use of diabetes medications other than metformin in the past 12 weeks, including exenatide
- Use of weight loss drugs or initiation of a weight loss program in past 3 months
- Impaired renal function or history of kidney transplant
- History of gall stones (unless s/p cholecystectomy), pancreatitis or alcoholism
- Personal or family history of medullary carcinoma of the thyroid or MEN type 2
Show all 12Show fewer
- History of gastroparesis or other gastric motility problems as exenatide decreases gastric motility
- History of allergic reaction to exenatide or other medication components
- Other significant comorbidities other than pituitary deficiencies
- Currently prescribed warfarin (exenatide may alter warfarin metabolism)
- Pregnant or lactating females
- History of severe hypoglycemia (BG <60 and requiring assistance from another person)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity
The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion.
Read the detailed description
Hypothalamic obesity occurs in up to 60% of patients with tumors in the hypothalamic region, most commonly craniopharyngiomas. Hypothalamic dysfunction can be due to tumor infiltration and as a consequence of surgery or radiation therapy. Survivors who develop obesity have greater morbidity and mortality than normal weight survivors. Prevention and treatment of obesity in this population is vital in order to decrease the morbidity and mortality from diabetes, stroke and myocardial infarction.
Exenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2 diabetes in 2005. It also decreases the rate of gastric emptying and increases satiety and has been shown to cause weight loss in some people. Exenatide may improve insulin sensitivity and satiety in patients with hypothalamic obesity but without the risks of bariatric surgery. The investigators hypothesize that treatment with exenatide will lead to weight loss in patients with hypothalamic obesity.
- Conditions
- Obesity, Overweight, Craniopharyngioma
- Being tested
- Exenatide
- Keywords
- Exenatide, Byetta, Hypothalamic Obesity, Obesity, Craniopharyngioma
- Medical subject headings
- Obesity, Overweight, Craniopharyngioma, Sexual Infantilism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | All patients received exenatide 10mcg BID x 50 weeks Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight (kg)
Change in body weight from baseline to end of study
Measured: baseline, 50 weeks
Secondary outcomes (4)
Resting Energy Expenditure (Kcals Per Day)
Change in resting energy expenditure from baseline to 50 weeks
Measured: baseline, 50 weeks
Visual Analogue Scales for Post-meal Satiety
Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).
Measured: baseline, 50 weeks
Insulin Secretion (Area Under the Curve)
Change in insulin secretion from baseline
Measured: baseline, 50 weeks
Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)
Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks
Measured: baseline, 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJun 2012
- Primary completionMar 2015
- Study completionMar 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Shoemaker, Vanderbilt University Medical Center
- Investigators
- Ashley Shoemaker, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484873
- Sponsor's protocol ID
- 111185
- Status last verified
- Jan 2017
- First submitted
- 20 Oct 2011
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lomenick JP, Buchowski MS, Shoemaker AH. A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity. Obesity (Silver Spring). 2016 Jun;24(6):1222-5. doi: 10.1002/oby.21493. Epub 2016 May 2.
PubMed 27133664
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity
- ClinicalTrials.gov ID
- NCT01484873
- Acronym / sponsor ID
- 111185
- Conditions
- Obesity, Overweight, Craniopharyngioma
- Keywords
- Exenatide, Byetta, Hypothalamic Obesity, Obesity, Craniopharyngioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Posted 11 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion.
Detailed description
Hypothalamic obesity occurs in up to 60% of patients with tumors in the hypothalamic region, most commonly craniopharyngiomas. Hypothalamic dysfunction can be due to tumor infiltration and as a consequence of surgery or radiation therapy. Survivors who develop obesity have greater morbidity and mortality than normal weight survivors. Prevention and treatment of obesity in this population is vital in order to decrease the morbidity and mortality from diabetes, stroke and myocardial infarction.
Exenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2 diabetes in 2005. It also decreases the rate of gastric emptying and increases satiety and has been shown to cause weight loss in some people. Exenatide may improve insulin sensitivity and satiety in patients with hypothalamic obesity but without the risks of bariatric surgery. The investigators hypothesize that treatment with exenatide will lead to weight loss in patients with hypothalamic obesity.
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: ExenatideAll patients received exenatide 10mcg BID x 50 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 40 years old
- History of craniopharyngioma or other lesion in the hypothalamic region
- Greater than 6 months post-treatment, including chemotherapy, surgery or radiation
- BMI >30 mg/m2
- Females must be post-menopausal, surgically sterile or using effective birth control for at least 12 weeks
Key exclusion criteria (12 listed)
- HgbA1C >7%
- Use of diabetes medications other than metformin in the past 12 weeks, including exenatide
- Use of weight loss drugs or initiation of a weight loss program in past 3 months
- Impaired renal function or history of kidney transplant
- History of gall stones (unless s/p cholecystectomy), pancreatitis or alcoholism
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: ByettaTreatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks. | Drug | Exenatide |
Primary outcome
Body Weight (kg)
Time frame: baseline, 50 weeks
Change in body weight from baseline to end of study
4 secondary outcomes
Resting Energy Expenditure (Kcals Per Day)
Time frame: baseline, 50 weeks
Visual Analogue Scales for Post-meal Satiety
Time frame: baseline, 50 weeks
Insulin Secretion (Area Under the Curve)
Time frame: baseline, 50 weeks
Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)
Time frame: baseline, 50 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27133664Lomenick JP, Buchowski MS, Shoemaker AH. A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity. Obesity (Silver Spring). 2016 Jun;24(6):1222-5. doi: 10.1002/oby.21493. Epub 2016 May 2.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Ashley Shoemaker, M.D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exenatide in people with Obesity and Overweight, run by Vanderbilt University Medical Center at 1 site 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 5 inclusion and 12 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 11 Aug 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?
Body Weight (kg) (time frame: baseline, 50 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01484873, which also lists 1 linked publication.
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 3 Mar 2017.