Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03578887 · ClinicalTrials.gov registry record · NA

A Cohort Study of Weight Loss and Gliosis

A NA study of Obesity, Gliosis, Weight-Loss, sponsored by University of Washington.

Completed
Registry status
NA
Development phase
112
Enrollment target
1
Study location

NCT03578887 is a NA study of Obesity, Gliosis, Weight-Loss that has completed, run by University of Washington. The registered enrollment target is 112 participants. The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03578887, a NA study of Obesity, Gliosis, Weight-Loss, has completed, sponsored by University of Washington.

COMPLETED
Registry status
NA
Development phase
112 participants
Enrollment target
1
Study location

Study Summary

Patients and clinicians need better options to prevent the weight regain that almost universally follows a weight loss intervention. In lay terms, a new, higher "set point" seems to occur after people gain weight. Evidence from some research studies reinforces these observations, showing that processes of energy homeostasis vigorously defend the higher level of adiposity for years, if not permanently. Only bariatric surgery appears to "re-set" to a lower level of adiposity. No clear mechanism has been elucidated to date that explains these phenomena. The current proposal endeavors to address this crucial scientific gap by translating preclinical data into human studies testing novel mechanistic hypotheses. Prior studies in rodents show that a high-fat diet causes inflammation and a cellular response, known as gliosis, within hypothalamic regions regulating energy balance and glucose homeostasis. Evidence further suggests that gliosis might play a pathogenic role in obesity and type 2 diabetes mellitus (T2D) because its development precedes weight gain and impaired glucose homeostasis and its inhibition improves metabolic health. Importantly, gliosis is detectable in mice and humans by magnetic resonance imaging (MRI). Using MRI, the investigators discovered the first evidence of gliosis in obese humans and went on to show associations of gliosis with insulin resistance in humans, independent of the level of adiposity. New findings suggest that people with T2D have more extensive gliosis than is seen in nondiabetic obese subjects. Further findings reveal that gliosis improves, but is not completely reversed, 8 mo. after Roux-en-Y gastric bypass (RYGB) surgery in T2D patients. It remains unknown whether gliosis improves similarly when weight loss occurs by lifestyle change or if the efficacy and durability of weight loss via bariatric surgery is partially explained by its ability to reverse gliosis via an as yet unknown mechanism of action. We therefore propose three

Interventions

  • BEHAVIORAL Behavioral Weight Loss Program
  • PROCEDURE Roux-en-Y Gastric Bypass or Sleeve Gastrectomy

Study Locations (1)

Washington

  • University of Washington - South Lake Union - Seattle

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2019-06-01
Est. Completion 2025-06-30
Phase NA

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT03578887

The ClinicalTrials.gov registry entry for NCT03578887 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obesity, Gliosis, Weight-Loss appearing as the primary indexed condition, and to 2 interventions - of which Behavioral Weight Loss Program is the first listed.

NCT03578887 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT03578887 about?

NCT03578887 is a clinical study titled "A Cohort Study of Weight Loss and Gliosis". Patients and clinicians need better options to prevent the weight regain that almost universally follows a weight loss intervention. In lay terms, a new, higher "set point" seems to occur after people gain weight. Evidence from some research studies reinforces these observations, showing that proces...

What is the current status of trial NCT03578887?

This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2019-06-01. Estimated completion is 2025-06-30.

What conditions does trial NCT03578887 study?

This clinical trial studies the following conditions: Obesity, Gliosis, Weight-Loss.

What interventions are being tested in trial NCT03578887?

The interventions under investigation include: Behavioral Weight Loss Program (BEHAVIORAL), Roux-en-Y Gastric Bypass or Sleeve Gastrectomy (PROCEDURE).

Who is sponsoring clinical trial NCT03578887?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03578887 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.