Evidence map›Paper›PMID 36087842›Full record

ArticleContemporary clinical trials2022

A randomized, double-blind, placebo-controlled clinical trial of 8-week intranasal oxytocin administration in adults with obesity: Rationale, study design, and methods.

Marie-Louis Wronski, Franziska Plessow, Liya Kerem, Elisa Asanza, Michelle L O'Donoghue, Fatima C Stanford, Miriam A Bredella, Martin Torriani, Alexander A Soukas, Arvin Kheterpal and 6 more

Erratum issuedOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 4 institutions in 2 countries.

Marie-Louis WronskiNeuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Translational Developmental Neuroscience Section, Division of Psychological and Social Medicine and Developmental Neurosciences, Faculty of Medicine, TU Dresden, Dresden, Germany.
Franziska PlessowNeuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Liya KeremDivision of Pediatric Endocrinology, Department of Pediatrics, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
Elisa AsanzaNeuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Michelle L O'DonoghueTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Fatima C StanfordNeuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Pediatric Endocrinology, Department of Pediatrics, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Miriam A BredellaDivision of Musculoskeletal Imaging and Intervention, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Martin TorrianiDivision of Musculoskeletal Imaging and Intervention, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Alexander A SoukasCenter for Genomic Medicine, Diabetes Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Arvin KheterpalDivision of Musculoskeletal Imaging and Intervention, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Kamryn T EddyEating Disorders Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Tara M HolmesTranslational and Clinical Research Centers, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Thilo DeckersbachDiploma Hochschule/University of Applied Sciences, Bad Sooden-Allendorf, Germany.
Mark VangelBiostatistics Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Laura M HolsenDivision of Women's Health, Department of Medicine and Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Elizabeth A LawsonNeuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: ealawson@partners.org.
Massachusetts General Hospital · USHarvard University · USHadassah Medical Center · ILThrombolysis in Myocardial Infarction Study Group · US

Funding

ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI CHRISTOPHER P DUGGAN · 1994 to 2026
$31.6M
Transgenic CoreP30DK046200 · NIDDK · TUFTS MEDICAL CENTER · PI CORKEY, BARBARA E. · 1992 to 2021
$25.0M
P&F programP30DK135043 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Aaron S Leong · 2023 to 2026
$5.4M
Oxytocin and Weight Loss in HumansR01DK109932 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI LAWSON, ELIZABETH AUSTEN · 2017 to 2020
$2.7M
Neurobiology of avoidant/restrictive eating in youthK24MH120568 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI LAWSON, ELIZABETH AUSTEN · 2019 to 2023
$961k
NIDDK NIH HHS P30 DK040561NIDDK NIH HHS P30 DK046200NIDDK NIH HHS P30 DK135043NIDDK NIH HHS R01 DK109932NIMH NIH HHS K24 MH120568
6 · The paper itself

Abstract

backgroundObesity affects more than one-third of adults in the U.S., and effective treatment options are urgently needed. Oxytocin administration induces weight loss in animal models of obesity via effects on caloric intake, energy expenditure, and fat metabolism. We study intranasal oxytocin, an investigational drug shown to reduce caloric intake in humans, as a potential novel treatment for obesity.

methodsWe report the rationale, design, methods, and biostatistical analysis plan of a randomized, double-blind, placebo-controlled clinical trial of intranasal oxytocin for weight loss (primary endpoint) in adults with obesity. Participants (aged 18-45 years) were randomly allocated (1:1) to oxytocin (four times daily over eight weeks) versus placebo. Randomization was stratified by biological sex and BMI (30 to <35, 35 to <40, ≥40 kg/m

resultsSixty-one male and female participants aged 18-45 years were randomized (mean age 34 years, mean BMI 37 kg/m

conclusionInvestigating intranasal oxytocin's efficacy, safety, and mechanisms as an anti-obesity medication will advance the search for optimal treatment strategies for obesity and its associated severe sequelae.

Indexed as

ObesityOxytocinAdministration, IntranasalAdultAnimalsDouble-Blind MethodFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicTreatment OutcomeWeight LossOxytocinAppetite regulationEnergy metabolismNeuroimagingObesityOxytocinWeight loss

Identifiers

PMID36087842
PMCPMC10329413
OpenAlexW4294904689

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.