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Modeling the Neurological Basis and Characterizing the Neurological Phenotype of Obesity Using Human Neural Stem Cells

NCT ID: NCT03263390

Last Updated: 2020-12-16

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-05

Study Completion Date

2020-08-10

Brief Summary

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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.

Detailed Description

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The investigators will consent subjects who have achieved extreme response to either bariatric surgery or pharmacologic treatment for obesity and harvest fibroblasts from skin biopsies, which will be reprogrammed to induced pluripotent stem cells (iPSC). These iPSC's will then be differentiated into neural progenitor cells, neurons, astrocytes, and microglia to identify genetic and epigenetic pathways altered in disease-specific neural progenitor cells of the brain.

Conditions

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Obesity, Morbid

Keywords

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Obesity Bariatric Surgery Anti Obesity Medications Weight Regulation Pluripotent Stem Cells

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Bariatric Surgery

Subjects that have demonstrated extreme response to bariatric surgery.

Bariatric Surgery

Intervention Type PROCEDURE

Sleeve gastrectomy or Roux-en-Y Gastric Bypass

Anti Obesity Medications

Subjects that have demonstrated extreme response to anti obesity pharmacotherapy.

Anti Obesity Drugs

Intervention Type DRUG

Response to FDA approved anti obesity medications

Interventions

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Bariatric Surgery

Sleeve gastrectomy or Roux-en-Y Gastric Bypass

Intervention Type PROCEDURE

Anti Obesity Drugs

Response to FDA approved anti obesity medications

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Grunvald

Clinical Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eduardo Grunvald, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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University of California San Diego

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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170097

Identifier Type: -

Identifier Source: org_study_id