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

Terminated

• Conditions: Obesity, Morbid
• Interventions: Procedure: Bariatric Surgery; Drug: Anti Obesity Drugs

• Registration Number: NCT03263390
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-28
• Study Start: 2017-10-05
• Primary Completion: 2020-08-10
• Study Completion: 2020-08-10
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-12
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bariatric Surgery	Bariatric Surgery	Subjects that have demonstrated extreme response to bariatric surgery.
Anti Obesity Medications	Anti Obesity Drugs	Subjects that have demonstrated extreme response to anti obesity pharmacotherapy.

Primary Outcome Measures

Name	Time	Method
Generate human cell based models of obesity	4 months	Fibroblasts will be expanded in culture and then reprogrammed to hiPSCs.
DNA sequencing	4 months	Perform DNA sequencing from skin biopsy progenitor cells
Identification of genetic and epigenetic pathways	4 months	Identify genetic and epigenetic pathways altered in disease-specific neural progenitor cells, neurons, and non-neuronal cells of the brain
Differentiation to human CNS cells	4 months	Disease specific hiPSCs cells will be differentiated into neural progenitor cells, neurons, astrocytes, and microglia

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States