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Weight Loss Interventions for Obesity
N/A
Waitlist Available
Led By Ellen Schur, MD, MS
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Behavioral Weight Loss (BWL) & Surgical Weight Loss (SWL) (Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy): BMI 30- <56 kg/m²
Aged 25-64 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 12-month follow-up after intervention
Awards & highlights
Study Summary
This trial is testing whether a weight loss intervention can improve or reverse a cellular response in the brain (gliosis) that is associated with weight regain.
Who is the study for?
This trial is for adults aged 25-64 with obesity, who are eligible for weight loss surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) and have a BMI of 30-<56 kg/m². Healthy individuals with a BMI of 18.5-24.9 can also participate as controls. Exclusions include poorly controlled hypertension, severe chronic diseases, certain medication use, pregnancy, MRI contraindications, smokers or heavy alcohol users.Check my eligibility
What is being tested?
The study tests if hypothalamic gliosis related to obesity and diabetes can be reversed by behavioral weight loss programs or bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy). It will examine the role of brain inflammation in maintaining higher body weights after initial weight loss.See study design
What are the potential side effects?
Potential side effects from the interventions may include typical risks associated with bariatric surgery such as nutritional deficiencies, gastrointestinal symptoms like nausea and vomiting, surgical complications; while lifestyle changes might lead to fatigue or muscle strains.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 30 and less than 56 kg/m².
Select...
I am between 25 and 64 years old.
Select...
I am eligible for and planning to have a first-time RYGB or Sleeve Gastrectomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during 12-month follow-up after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 12-month follow-up after intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight Loss
Weight Regain
Trial Design
3Treatment groups
Active Control
Group I: Lifestyle CohortActive Control1 Intervention
Participants Undergoing Behavioral Weight Loss Program
Group II: Surgical CohortActive Control1 Intervention
Participants Scheduled for Roux-en-Y Gastric Bypass Surgery
Group III: Healthy Weight Control CohortActive Control1 Intervention
Healthy Weight Controls With No Intervention
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,239 Total Patients Enrolled
30 Trials studying Obesity
4,139 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,314,954 Total Patients Enrolled
446 Trials studying Obesity
588,826 Patients Enrolled for Obesity
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,384 Total Patients Enrolled
251 Trials studying Obesity
205,944 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is between 30 and less than 56 kg/m².I am currently using insulin, DPP-4 inhibitors, thiazolidinediones, or medications that can change how my body processes energy.I am between 25 and 64 years old.I have cirrhosis, including from fatty liver disease.I have had or am planning to have obesity surgery or use a weight loss device.I cannot have an MRI due to metal implants, fear of tight spaces, or size.I have type 2 diabetes.I have a history of or currently have an eating disorder, am in a weight loss program, or take weight loss medications.My A1c level is above the required threshold for my group.My kidney function is reduced.I have uncontrolled high blood pressure, heart issues, or a chronic condition like cancer.I am eligible for and planning to have a first-time RYGB or Sleeve Gastrectomy.
Research Study Groups:
This trial has the following groups:- Group 1: Lifestyle Cohort
- Group 2: Surgical Cohort
- Group 3: Healthy Weight Control Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to enroll in this experiment?
"This study is targeting 145 obese individuals aged 25 to 64. The prerequisites for participation include a BMI between 18.5 and 24.9 kg/m², eligibility for either Roux-en-Y Gastric bypass or Sleeve Gastrectomy surgery, but not undergoing any revisional operations of these procedures at the time of recruitment."
Answered by AI
How many individuals are currently involved in the research?
"Affirmative, the information on clinicaltrials.gov affirms that this experiment is presently recruiting volunteers. It was initially posted on June 1st 2019 and most recently modified November 9th 2022. 145 individuals must be recruited from a single site for participation in the trial."
Answered by AI
Does this research endeavor accept individuals over the age of 25?
"This research endeavour is looking for participants aged 25 or older but younger than 64."
Answered by AI
Are there any open opportunities to partake in this clinical investigation?
"Absolutely. According to clinicaltrials.gov, this medical examination is actively searching for 145 participants from a single site since it was initially posted on June 1st 2019 and edited lastly on November 9th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
University of Washington - South Lake Union
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have an abdominal aortic aneurysm, the condition which killed my mother, and since weight loss improves survival, I need to continue to lose weight.
PatientReceived 1 prior treatment
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