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

December 12, 2020 updated by: Eduardo Grunvald, University of California, San Diego
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with obesity who are considered super responders to bariatric surgery or anti obesity pharmacotherapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bariatric Surgery
Subjects that have demonstrated extreme response to bariatric surgery.
Procedure: Bariatric Surgery
Sleeve gastrectomy or Roux-en-Y Gastric Bypass
Anti Obesity Medications
Subjects that have demonstrated extreme response to anti obesity pharmacotherapy.
Drug: Anti Obesity Drugs
Response to FDA approved anti obesity medications

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Eduardo Grunvald, MD, UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2017

Primary Completion (Actual)

August 10, 2020

Study Completion (Actual)

August 10, 2020

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (Actual)

August 28, 2017

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 12, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is not an intervention trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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