CClinicalTrials.gg
TerminatedNCT03263390Updated Dec 16, 2020

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

An observational study in Obesity, Morbid, sponsored by University of California, San Diego. Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-12-16.

Sponsored by University of California, San Diego · Observational

Why this study was terminated
Study terminated by study partners
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
6
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obesity, Morbid

Keywords

  • Obesity
  • Bariatric Surgery
  • Anti Obesity Medications
  • Weight Regulation
  • Pluripotent Stem Cells
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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.

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

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
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
6 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Bariatric Surgery

    Subjects that have demonstrated extreme response to bariatric surgery.

    Procedure: Bariatric Surgery

  • Anti Obesity Medications

    Subjects that have demonstrated extreme response to anti obesity pharmacotherapy.

    Drug: Anti Obesity Drugs

Interventions

  • ProcedureBariatric Surgery

    Sleeve gastrectomy or Roux-en-Y Gastric Bypass

  • DrugAnti Obesity Drugs

    Response to FDA approved anti obesity medications

05

What researchers measure

Primary outcomes

  1. DNA sequencing

    Perform DNA sequencing from skin biopsy progenitor cells

    Time frame: 4 months

  2. Generate human cell based models of obesity

    Fibroblasts will be expanded in culture and then reprogrammed to hiPSCs.

    Time frame: 4 months

  3. Differentiation to human CNS cells

    Disease specific hiPSCs cells will be differentiated into neural progenitor cells, neurons, astrocytes, and microglia

    Time frame: 4 months

  4. 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

    Time frame: 4 months

06

Study locations

1 site
  • University of California San Diego
    La Jolla, California 92037, United States
07

References and documents

Individual participant data

Plan to share: No — This is not an intervention trial

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03263390
Lead sponsor
University of California, San Diego
Responsible party
Eduardo Grunvald (Clinical Professor of Medicine, University of California, San Diego) — Principal investigator
First posted
Aug 28, 2017
Start date
Oct 5, 2017
Primary completion
Aug 10, 2020
Completion
Aug 10, 2020
Last update
Dec 16, 2020

Study contacts

Eduardo Grunvald, MD
principal investigator · UCSD

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion