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Obesity, Gliosis, Weight-LossNCT03578887

A Cohort Study of Weight Loss and Gliosis

A study testing Behavioral Weight Loss Program and Roux-en-Y Gastric Bypass or Sleeve Gastrectomy in people with Obesity, Gliosis, Weight-Loss, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Gliosis, Weight-Loss
What is being tested?
Behavioral Weight Loss Program and Roux-en-Y Gastric Bypass or Sleeve Gastrectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteUnited States
Study dates
1 Jun 2019to 30 Jun 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 25 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 25-64 years
  • Behavioral Weight Loss (BWL) \& Surgical Weight Loss (SWL) (Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy): BMI 30- <56 kg/m²
  • RYGB and Sleeve Gastrectomy: eligible for RYGB or Sleeve Gastrectomy and not undergoing revision or reoperation
  • Healthy Weight Controls (HWC): BMI 18.5-24.9 kg/m²

Who cannot join

  • Poorly controlled hypertension or coronary artery disease, or chronic disease (e.g. cancer, multiple sclerosis, autoimmune disease, rheumatic disease) Blood Pressure > 160/100 mmHG Heart Rate > 110 bpm
  • Chronic kidney disease (GFR <60 mL/min/1.73 m2),
  • Presence of cirrhosis (Nonalcoholic Fatty Liver Disease (NALFD)/Nonalcoholic Steatohepatitis (NASH) are acceptable),
  • Previous or planned (during the study period) obesity treatment with surgery (planned surgery ok for the SWL group) or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening,
  • A1c > 8.5% in Bariatric group; A1c ≥ 6.5% for BWL and HWC groups,
  • Current use of insulin (insulin ok for Surgical Weight Loss group, also called SWL), DPP-4 inhibitors, thiazolidinediones or medications known to alter metabolic function (e.g. atypical antipsychotics, corticosteroids),
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  • Pregnancy or breastfeeding,
  • MRI contraindications (e.g. implanted metal, claustrophobia), or unable to have MRI or fit in MRI scanner
  • Current smoking/daily use of nicotine containing products (cigarettes, e-cigarettes, vaping or other nicotine containing products) or heavy alcohol use,
  • Weight >450 pounds (iDXA limit),
  • Weight-reduced from lifetime maximum weight by >16%,
  • Weight not stable over past 3 months (±10%),
  • T2D (for BWL or HWC),
  • Inability to participate in a weight loss program (BWL)
  • History of eating disorder or current eating disorder, currently enrolled in a weight loss program (ok for the SWL group provided weight stability and lifetime weight-reduced maximum conditions are met) or taking medications to lose weight
  • Severe food allergies
  • Any condition that the study physician determines to be unsafe for participation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Washington - South Lake Union

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Twin Study of Obesity Pathogenesis Using fMRI

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 studies in humans to discover 1) if hypothalamic gliosis is reversed by a standard behavioral weight loss intervention, 2) if the extent of gliosis predicts successful weight loss during, or weight regain after, behavioral weight loss, and 3) the time course of improvement in gliosis after RYGB and the relation of its improvement to the short- and long-term efficacy of RYGB. Future research would define dietary, environmental, or other risk factors for the development of hypothalamic gliosis in humans. Achieving a better understanding of the role of the brain in obesity and its treatment could open new avenues for research, intervention, and prevention.

Being tested
Behavioral Weight Loss Program, Roux-en-Y Gastric Bypass or Sleeve Gastrectomy
Keywords
Obesity, Gliosis, Weight-Loss, Roux-en-Y Gastric Bypass, Type 2 Diabetes Mellitus
Medical subject headings
Obesity, Gliosis, Weight Loss, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral Weight Loss ProgramBehavioural

    Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program (DPP).

  • Roux-en-Y Gastric Bypass or Sleeve GastrectomyProcedure or surgery

    Subjects undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy with their own surgical team

Study groups in NCT03578887
Study groupRoleWhat they receive
Lifestyle CohortActive comparatorParticipants Undergoing Behavioral Weight Loss Program
Receives: Behavioral: Behavioral Weight Loss Program
Surgical CohortActive comparatorParticipants Scheduled for Roux-en-Y Gastric Bypass Surgery
Receives: Procedure: Roux-en-Y Gastric Bypass or Sleeve Gastrectomy
Healthy Weight Control CohortNo interventionHealthy Weight Controls With No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Weight From Baseline

    Measured: During 6 Month Behavioral Weight Loss Program

  2. Weight Regain

    Change in Weight (kg) during 12 month follow-up period

    Measured: During 12-Month Follow-Up After Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start1 Jun 2019
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03578887
Sponsor's protocol ID
STUDY00002978
Other IDs
2R01DK089036-06, 1K24HL144917-01A1
Status last verified
Aug 2025
First submitted
25 Jun 2018
Last updated
4 Sep 2025
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Weight Loss Program and Roux-en-Y Gastric Bypass or Sleeve Gastrectomy in people with Obesity, Gliosis, Weight-Loss, run by University of Washington 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 4 Sep 2025. 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?

Yes. Results are posted in the registry (first posted 28 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in Weight From Baseline (time frame: During 6 Month Behavioral Weight Loss Program). The study lists 2 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 4 Sep 2025.

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