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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03263390
• Other study ID #: 170097
• Status: Terminated
• Start date: October 5, 2017
• Est. completion date: August 10, 2020

Study information

• Verified date: December 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 10, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Bariatric Surgery
Sleeve gastrectomy or Roux-en-Y Gastric Bypass

Drug:
• Anti Obesity Drugs
Response to FDA approved anti obesity medications

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA sequencing	Perform DNA sequencing from skin biopsy progenitor cells	4 months
Primary	Generate human cell based models of obesity	Fibroblasts will be expanded in culture and then reprogrammed to hiPSCs.	4 months
Primary	Differentiation to human CNS cells	Disease specific hiPSCs cells will be differentiated into neural progenitor cells, neurons, astrocytes, and microglia	4 months
Primary	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