Oksytocin for vekttap hos ungdom
Oksytocin som en nevroendokrin terapi for fedme hos ungdom
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In recent years there has been a dramatic increase in obesity and its complications in both children and adults. Earlier treatment substantially reduces the likelihood of developing complications later in life while concurrently improving quality of life and decreasing mortality. Therefore, it is essential to develop safe and effective therapeutic strategies for weight loss, particularly in adolescents. Oxytocin (OXT), a hypothalamic peptide hormone that regulates energy balance, is a novel neuroendocrine weight-loss therapeutic in adults with obesity because it simultaneously reduces energy intake and increases energy expenditure and is well-tolerated. Data are currently lacking regarding effects of OXT administration in adolescents with obesity.
The current study is a 12-week randomized controlled trial (RCT) of OXT vs. placebo in 10-18-year old adolescents with obesity. We hypothesize that OXT administration will decrease weight as a consequence of decreased caloric intake and increased energy expenditure, both partially mediated by reduced hypothalamic inflammation (such inflammation drives weight gain by increasing food intake and reducing energy expenditure). Further, OXT will improve metabolic risk markers, such as visceral and intrahepatic fat, systemic inflammation, and serum lipids.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Elizabeth A Lawson, MD, MMSc
- Telefonnummer: 617-726-3870
- E-post: ealawson@partners.org
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Rekruttering
- Massachusetts General Hospital
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Ta kontakt med:
- Elizabeth A Lawson, MD
- E-post: ealawson@partners.org
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Males and Females, 10-18 years
- Obesity (BMI ≥95th percentile for age and gender)
- Willingness to maintain current diet and lifestyle for the duration of study participation
Exclusion Criteria:
- Current substance abuse
- Use of prescription or over-the-counter drugs or dietary/herbal supplements that may affect weight if dose increased in the three months preceding the baseline visit and/or if they plan to increase the dose during the 18 weeks of study participation.
- Greater than 5kg weight loss over 3 months;
- Follows a nonstandard diet (e.g., Paleo, Atkins, raw diet, macrobiotic diet)
- Cardiovascular disease
- Prolonged QT interval
- Chronic inflammatory bowel disease and other inflammatory conditions
- Epilepsy
- TSH > 2.5 times upper limit of normal
- Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times upper limit of normal
- Creatinine >1.5 mg/dl
- Hyponatremia
- Pregnancy/breastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active
- MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips
- Weight >450 lbs due to limits for MRI and DXA scanners
- Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c >8%
- Active eating disorder
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Oxytocin
Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks) |
24 IU nasal spray, 4 times per day for 12 weeks
Andre navn:
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Placebo komparator: Placebo
Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks) |
24 IU nasal spray, 4 times per day for 12 weeks |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body mass index (BMI)
Tidsramme: 12 weeks
|
Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2 |
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lean mass and Fat mass
Tidsramme: 12 weeks
|
Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg) |
12 weeks
|
|
Fasting Resting Energy Expenditure (kCal)
Tidsramme: 12 weeks
|
Assessed by Indirect calorimetry |
12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Elizabeth Lawson, MD, MMSc, Massachusetts General Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2020P002511
- 1R01DK124223-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data requested by specific investigator after deidentification (text, tables, figures, and appendices) after proposal is provided.
IPD-delingstidsramme
Following publication and ending 36 months following article publication.
Tilgangskriterier for IPD-deling
Researchers who provide a methodologically sound proposal will receive IPD to achieve aims in the approved proposal. Proposals should be directed to Drs. Lawson, Misra or Bredella. After approval, we will provide a copy of the requested data, as well as any additional required documentation, to the requesting researchers. The data will be housed on a secure password protected network drive at the MGH, that will be sent to investigators who ask for the data.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
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