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Effects of Exenatide on Hypothalamic Obesity
Plain-language guide to NCT01061775: phase 1, phase 2 interventional trial of Exenatide, 19 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01061775
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2010-01
- Completion (planned or actual)
- 2013-07
- Participants
- 19 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Hypothalamic Obesity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 1, phase 2 trial, researchers set out to test Exenatide.
It had 1 arm (groups): Exenatide (experimental).
The registry classes the interventions as drug.
More on the Plan
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.
Who Took Part
19 actual participants took part.
It was open to people of any sex aged from 10 years up to 21 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: \>/=6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors. 10-21 years old. Parent sign consent and patient sign assent.
The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: \< 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.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2010-01 with completion listed for 2013-07.
It ran at 2 sites in United States (2).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: BMI Change (time frame: 24 weeks). Waist to Height Ratio (WHtR) (time frame: 24 weeks).
It also tracked 2 secondary outcomes, for example Childhood Eating Behavior Questionnaire (CEBQ) and Calorie Intake Based on 3-day Diet Records.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2 trial of Exenatide in 19 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Exenatide compound page, all human trials.
Our Notes on the Compound
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.