Study Stopped
Study terminated by study partners
Modeling the Neurological Basis and Characterizing the Neurological Phenotype of Obesity Using Human Neural Stem Cells
1 other identifier
observational
6
1 country
1
Brief Summary
This study aims to characterize the neurological basis of obesity and response to surgical and medical treatment by inducing adult pluripotent stem cells into neuronal cells from subjects that have demonstrated extreme response to bariatric surgery or pharmacological treatment for obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 28, 2017
CompletedStudy Start
First participant enrolled
October 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2020
CompletedDecember 16, 2020
December 1, 2020
2.8 years
August 24, 2017
December 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
DNA sequencing
Perform DNA sequencing from skin biopsy progenitor cells
4 months
Generate human cell based models of obesity
Fibroblasts will be expanded in culture and then reprogrammed to hiPSCs.
4 months
Differentiation to human CNS cells
Disease specific hiPSCs cells will be differentiated into neural progenitor cells, neurons, astrocytes, and microglia
4 months
Identification of genetic and epigenetic pathways
Identify genetic and epigenetic pathways altered in disease-specific neural progenitor cells, neurons, and non-neuronal cells of the brain
4 months
Study Arms (2)
Bariatric Surgery
Subjects that have demonstrated extreme response to bariatric surgery.
Anti Obesity Medications
Subjects that have demonstrated extreme response to anti obesity pharmacotherapy.
Interventions
Eligibility Criteria
Subjects with obesity who are considered super responders to bariatric surgery or anti obesity pharmacotherapy.
You may qualify if:
- History of obesity
- Treatment with bariatric surgery
- Treatment with anti obesity medications
- Greater than 70% excess weight loss at least 6 months after surgery
- Greater than 15% weight loss on anti obesity medications
You may not qualify if:
- Active cancer, not including non-melanoma skin cancer
- Active eating disorder
- Use of anti obesity medications in subjects with a history of bariatric surgery
- Active complication of the upper GI tract in patients with a history of bariatric surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Diego
La Jolla, California, 92037, United States
Biospecimen
Fibroblasts, iPSCs, and DNA sequencing information generated from skin biopsies will be expanded and stored for potential future use.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Grunvald, MD
UCSD
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor of Medicine
Study Record Dates
First Submitted
August 24, 2017
First Posted
August 28, 2017
Study Start
October 5, 2017
Primary Completion
August 10, 2020
Study Completion
August 10, 2020
Last Updated
December 16, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share
This is not an intervention trial