Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03263390
Recruitment Status : Terminated (Study terminated by study partners)
First Posted : August 28, 2017
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Eduardo Grunvald, University of California, San Diego

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Obesity, Morbid Procedure: Bariatric Surgery Drug: Anti Obesity Drugs

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Modeling the Neurological Basis and Characterizing the Neurological Phenotype of Obesity Using Human Neural Stem Cells
Actual Study Start Date : October 5, 2017
Actual Primary Completion Date : August 10, 2020
Actual Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. DNA sequencing [ Time Frame: 4 months ]
    Perform DNA sequencing from skin biopsy progenitor cells

  2. Generate human cell based models of obesity [ Time Frame: 4 months ]
    Fibroblasts will be expanded in culture and then reprogrammed to hiPSCs.

  3. 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. 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


Biospecimen Retention:   Samples With DNA
Fibroblasts, iPSCs, and DNA sequencing information generated from skin biopsies will be expanded and stored for potential future use.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with obesity who are considered super responders to bariatric surgery or anti obesity pharmacotherapy.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263390


Locations
Layout table for location information
United States, California
University of California San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Layout table for investigator information
Principal Investigator: Eduardo Grunvald, MD UCSD
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Eduardo Grunvald, Clinical Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03263390    
Other Study ID Numbers: 170097
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not an intervention trial

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eduardo Grunvald, University of California, San Diego:
Obesity
Bariatric Surgery
Anti Obesity Medications
Weight Regulation
Pluripotent Stem Cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Anti-Obesity Agents