Clinical trial · Interventional
Effects of Exenatide on Hypothalamic Obesity
NCT01061775CI-TRIAL-00041047completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypothalamic Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exenatide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exenatide
- description
- 5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.
- interventionNames
- Drug: Exenatide
Primary outcomes (2)
- measure
- BMI Change
- timeFrame
- 24 weeks
- description
- BMI was collected at baseline and 24 weeks
- measure
- Waist to Height Ratio (WHtR)
- timeFrame
- 24 weeks
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.