Obesity, MorbidNCT03263390
Modeling the Neurological Basis and Characterizing the Neurological Phenotype of Obesity Using Human Neural Stem Cells
An observational study of Obesity, Morbid, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Bariatric Surgery and Anti Obesity Drugs
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 10 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with obesity who are considered super responders to bariatric surgery or anti obesity pharmacotherapy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92037
About this study
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.
Read the 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.
- Conditions
- Obesity, Morbid
- Being tested
- Bariatric Surgery, Anti Obesity Drugs
- Keywords
- Obesity, Bariatric Surgery, Anti Obesity Medications, Weight Regulation, Pluripotent Stem Cells
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
Sleeve gastrectomy or Roux-en-Y Gastric Bypass
Anti Obesity DrugsDrug
Response to FDA approved anti obesity medications
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Subjects that have demonstrated extreme response to bariatric surgery. Receives: Procedure: Bariatric Surgery | |
| Anti Obesity Medications | Subjects that have demonstrated extreme response to anti obesity pharmacotherapy. Receives: Drug: Anti Obesity Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA sequencing
Perform DNA sequencing from skin biopsy progenitor cells
Measured: 4 months
Generate human cell based models of obesity
Fibroblasts will be expanded in culture and then reprogrammed to hiPSCs.
Measured: 4 months
Differentiation to human CNS cells
Disease specific hiPSCs cells will be differentiated into neural progenitor cells, neurons, astrocytes, and microglia
Measured: 4 months
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start5 Oct 2017
- Primary completion10 Aug 2020
- Study completion10 Aug 2020
Why it stopped: Study terminated by study partners
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Grunvald, University of California, San Diego
- Investigators
- Eduardo Grunvald, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263390
- Sponsor's protocol ID
- 170097
- Status last verified
- Dec 2020
- First submitted
- 24 Aug 2017
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not an intervention trial
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling the Neurological Basis and Characterizing the Neurological Phenotype of Obesity Using Human Neural Stem Cells
- ClinicalTrials.gov ID
- NCT03263390
- Acronym / sponsor ID
- 170097
- Conditions
- Obesity, Morbid
- Keywords
- Obesity, Bariatric Surgery, Anti Obesity Medications, Weight Regulation, Pluripotent Stem Cells
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated by study partners
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | – | Procedure: Bariatric SurgerySubjects that have demonstrated extreme response to bariatric surgery. |
| Anti Obesity Medications | – | Drug: Anti Obesity DrugsSubjects that have demonstrated extreme response to anti obesity pharmacotherapy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with obesity who are considered super responders to bariatric surgery or anti obesity pharmacotherapy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgerySleeve gastrectomy or Roux-en-Y Gastric Bypass | Procedure or surgery | Bariatric Surgery |
| Anti Obesity DrugsResponse to FDA approved anti obesity medications | Drug | Anti Obesity Medications |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Study terminated by study partners). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: No. This is not an intervention trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Grunvald, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated by study partners). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA sequencing (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.