Genetic Testing and Phenotypic Characterization of Severely Obese Pediatric and Adult Volunteers
NCT ID: NCT02849977
Last Updated: 2022-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5966 participants
OBSERVATIONAL
2016-09-28
2020-06-09
Brief Summary
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This screening study will not include any investigational drugs. You will be asked to provide a DNA sample and answer some questions about your medical history and hunger.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Cohort 1
If the subject has a history of hyperphagia, early onset obesity and/or clinical characteristics known to be related to mutations in the MC4R pathway and related to obesity (1.4 times 95th percentile in children).
No interventions assigned to this group
Cohort 2
If the subject has exponentially high BMI (≥50 to 59), without hyperphagia and early onset obesity, whose obesity may be driven by an MC4R pathway mutation in the absence of other clear history or clinical characteristics (1.5 - 1.6 times 95th percentile in children).
No interventions assigned to this group
Cohort 3
If the subject has exponentially high BMI (≥60), without hyperphagia and early onset obesity, whose obesity may be driven by an MC4R pathway mutation in the absence of other clear history or clinical characteristics (1.6 times 95th percentile in children).
No interventions assigned to this group
Cohort 4
If the subject has had or is undergoing bariatric surgery, who represents a refractory population of severely obese individuals whose obesity may be driven by an MC4R pathway mutation in the absence of other clear history or clinical characteristics (1.4 times 95th percentile in children and adolescents aged 12 and older).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Study participant and/or parent or guardian is able to communicate well with the investigator, to understand and comply with the requirements of the study, and be able to understand and sign the written informed consent/assent.
3. ≥40kg/m2 (age 18 and older) or 1.4x 95th percentile of BMI for age (ages 2-17) - with evidence of hunger or hyperphagia by screening surveys, indicated by a patient or observer score at or greater than midpoint of scale.
o Individuals with clinical evidence of RGDO (per appendix 4) but do not meet the BMI criteria may be included if the investigators estimation and proband demonstrates a BMI Z-score difference of \>1 between proband and any other sibling; and/or the proband demonstrates a BMI difference \>10 kg/m2 between proband and parents.
4. ≥50 kg/m2 (age 18 and older) or 1.5x 95th percentile of BMI for age (ages 2-17). Cohorts included under this criteria include ≥50-60 kg/m2 (age 18 and older) or 1.5x 95th percentile of BMI for age (ages 2-17) and ≥60 kg/m2 (age 18 and older) or 1.6x 95th percentile of BMI for age (ages 2-17).
5. ≥ 40 kg/m2 (pre-operative) or 1.4x 95th percentile of BMI for age (ages 12-17) with history of bariatric surgery or planned surgery within 3 months (prior to or following screening).
Exclusion Criteria
2. Diagnosis of Prader-Willi syndrome
2 Years
ALL
No
Sponsors
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Rhythm Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Meeker
Role: STUDY_CHAIR
Rhythm Pharmceuticals, Inc.
Locations
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Synexus Clinical Research US, Inc. - Simon Williamson Clinic, PC
Birmingham, Alabama, United States
Synexus Clinical Research US, Inc. - Phoenix Southeast
Chandler, Arizona, United States
Clinical Research Advantage Inc.
Mesa, Arizona, United States
Tucson Neuroscience Research - M3 Wake Research
Tucson, Arizona, United States
Encino, California, United States
PRI, LLC - Los Alamitos - M3 Wake Research
Los Alamitos, California, United States
Axis Clinical Trails
Los Angeles, California, United States
Axis Clinical Trials
Los Angeles, California, United States
PRI, LLC - Newport Beach - M3 Wake Research
Newport Beach, California, United States
Nemours Foundation Alfred Dupont Children's Hospital
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
South Florida Clinical Trials
Hialeah, Florida, United States
Translational Research Inst. for Metabolism and Diabetes
Orlando, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Palm Harbor Medical Associates - BTC - PPDS
Palm Harbor, Florida, United States
Synexus Clinical Research US, Inc. - St. Petersburg
Pinellas Park, Florida, United States
Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois, United States
Maine Medical Partners Pediatric Specialty Care
Portland, Maine, United States
Baystate Children's Hospital, Division of Pediatric Endocrinology
Springfield, Massachusetts, United States
Helen DeVos Children's Hospital Healthy Weight Center
Grand Rapids, Michigan, United States
Synexus Clinical Research US, Inc. - West Florissant Internists
Bridgeton, Missouri, United States
Impact Clinical Trials - Las Vegas
Las Vegas, Nevada, United States
University of New Mexico
Albuquerque, New Mexico, United States
New York Clinical Trials-Brooklyn
Brooklyn, New York, United States
Division of Endocrinology/Diabetes Amanda House
Buffalo, New York, United States
Cohen Children's Medical Center of NY
Lake Success, New York, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
New York Clinical Trials-Manhattan
New York, New York, United States
UNC Health Care - NC Children's Specialty Clinic
Chapel Hill, North Carolina, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Synexus Clinical Research US, Inc. - Akron
Akron, Ohio, United States
Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati, Ohio, United States
Nationwide Children's Hospital, Center for Healthy Weight and Nutrition
Columbus, Ohio, United States
Synexus Clinical Research US, Inc. - Columbus
Columbus, Ohio, United States
Synexus Clinical Research US, Inc. - Centennial Health, PC -
Oklahoma City, Oklahoma, United States
Synexus Clinical Research US, Inc. - Primary Care Associates
Anderson, South Carolina, United States
University of Tennesseee Health Science Center
Memphis, Tennessee, United States
Medical Research Center of Memphis, LLC - M3 Wake Research
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center
Amarillo, Texas, United States
Synexus - Synexus US, LP - Dallas
Dallas, Texas, United States
Global Medical Research - M3 Wake Research
DeSoto, Texas, United States
Synexus Clinical Research US, Inc. - San Antonio
San Antonio, Texas, United States
University of Utah, Department of Surgery
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Alberta
Edmonton, Alberta, Canada
Charite Campus Virchow-Klinikum Institute for Experimental Pediatric Endocrinology
Berlin, , Germany
University of Hospital of Patras
Pátrai, , Greece
Rabin Medical Center - PPDS
Petah Tikva, , Israel
Schneider Children's Medical Center of Israel - Petah Tikvah - PIN
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
IRCCS Istituto Auxologico Italiano
Oggebbio, , Italy
Hospital Senhora da Oliveira -Guimaraes, E.P.E
Guimarães, , Portugal
Countries
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Other Identifiers
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RM-493-013
Identifier Type: -
Identifier Source: org_study_id
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