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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Obesity, Morbid | Procedure: Bariatric Surgery Drug: Anti Obesity Drugs |
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 |

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 |
- DNA sequencing [ Time Frame: 4 months ]Perform DNA sequencing from skin biopsy progenitor cells
- Generate human cell based models of obesity [ Time Frame: 4 months ]Fibroblasts will be expanded in culture and then reprogrammed to hiPSCs.
- Differentiation to human CNS cells [ Time Frame: 4 months ]Disease specific hiPSCs cells will be differentiated into neural progenitor cells, neurons, astrocytes, and microglia
- 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

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.
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 |
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

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
United States, California | |
University of California San Diego | |
La Jolla, California, United States, 92037 |
Principal Investigator: | Eduardo Grunvald, MD | UCSD |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Obesity Bariatric Surgery Anti Obesity Medications Weight Regulation Pluripotent Stem Cells |
Obesity Obesity, Morbid Overnutrition Nutrition Disorders |
Overweight Body Weight Anti-Obesity Agents |