Intranasal Oxytocin in Hypothalamic Obesity (NCT02849743) | Clinical Trial Compass
CompletedPhase 2
Intranasal Oxytocin in Hypothalamic Obesity
United States18 participantsStarted 2016-10
Plain-language summary
This research study will test if oxytocin, delivered by nasal spray, will promote weight loss in children, adolescents, and adults with Hypothalamic Obesity as compared to a placebo. The study is divided into two parts. During the first part, subjects will receive either oxytocin or placebo. In the second part, subjects will "cross-over" to receive the other treatment - either oxytocin or placebo. During study visits participants will do blood tests, physical exams, metabolic testing, a MRI scan, and some surveys and questionnaires.
Who can participate
Age range10 Years – 35 Years
SexALL
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Inclusion criteria
✓. Proficient in English.
✓. Males or females age 10 to 35 years, inclusive.
✓. Weight ≥ 51 kg.
✓. Girls must have a negative urine/serum pregnancy test and post-menarchal girls must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
✓. Hypothalamic obesity, defined for the purposes of this protocol as:
✓. At least 6 months since completion of therapy with stable disease/lack of recurrence.
✓. Stable for at least 2 months on any pituitary replacement (e.g., glucocorticoid, thyroid hormone, estrogen/progestin or testosterone, growth hormone, except for adjustments of less than or equal to 20%). (Desmopressin is not required to be stable for 2 months. Participants with DI taking desmopressin are required to have intact thirst and be well-controlled on their current dosing regimen.)
✓. Stable for at least 2 months on any appetite-modulating medications (e.g., stimulants).
Exclusion criteria
✕. Diabetes insipidus without intact thirst mechanism (i.e., history that participant is not thirsty when hypernatremic and/or continues to be thirsty when hyponatremic, by participant/family and/or practitioner report and medical records) and/or "brittle" diabetes insipidus, defined as requiring \>1 admission in the past year and/or any admission within the previous 3 months.
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What they're measuring
1
Weight Loss
Timeframe: Assessed at the beginning and end of each Intervention Period (Intervention 1: Visit 1 to Visit 4 = 8 Weeks, Intervention 2: Visit 5 to Visit 8 = 8 Weeks)
✕. Cardiovascular condition, as defined as any of the following: i) abnormal blood pressure, defined as \<3%ile or \>97%ile for age, sex and height; ii) history of cardiac arrhythmia or arrhythmia detected on screening ECG; iii) history of heart failure and/or cardiomyopathy; iv) prolonged QTc interval (QTc \> 460 msec), and/or long QT syndrome phenotype and/or positive genotype for long QT syndrome pathogenic mutations.
✕. Concurrent use of medications known to prolong QTc interval and pose high risk for Torsades de Pointes (TdP) according to the current information available (www.crediblemeds.org). Concomitant medications will be assessed by IDS pharmacist, in collaboration with study cardiologist, if additional clarification is needed. In addition, we require that potential participants be on a stable dose for at least 2 months of any medication with the potential to alter cardiac rhythm to ensure the screening ECG reflects steady-state physiology.
✕. History of liver disease, with screening laboratory studies:
✕. History of chronic kidney disease, with screening laboratory studies:
✕. Clinically significant anemia, with screening laboratory studies: