Bariatric Surgery for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how daily habits, such as eating and sleeping, influence gene behavior in fat cells, particularly in response to insulin, both before and after weight-loss surgery. The trial includes two groups: one will follow a strict schedule for meals and sleep before surgery, while the other will maintain their usual routines. It is suitable for women planning bariatric surgery who have struggled with obesity (BMI over 40) and are patients at the University of Chicago. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on how lifestyle affects genetic behavior.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using beta blockers.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that syncing the body's internal clock with natural day-night cycles can aid weight loss and improve health. Studies have found that aligning eating and sleeping with natural body rhythms often leads to greater weight loss and better sugar level management.
For instance, one study discovered that adjusting meal and sleep times can promote a healthier balance of body fat and muscle and improve how the body uses food for energy. Another study found that women who maintained regular sleep and meal times lost weight over several weeks.
These findings suggest that following the body's natural clock is generally safe and beneficial for health. No serious safety issues have been reported in these studies, making it a well-tolerated approach for most people.12345Why are researchers excited about this trial?
Researchers are excited about the approach of aligning the circadian clock as a treatment for obesity because it offers a non-invasive method to potentially enhance bariatric surgery outcomes. Traditional obesity treatments often involve medication or lifestyle changes focused primarily on diet and exercise. However, this approach aims to optimize the body's internal clock by regulating light exposure and meal timing, which may improve metabolism and overall health. By addressing the body's natural rhythms, this method could complement existing treatments and offer a novel way to support weight loss and improve health outcomes.
What evidence suggests that this trial's treatments could be effective for obesity?
This trial will compare two approaches related to circadian clock management for individuals undergoing bariatric surgery. Studies have shown that aligning the body's internal clock with daily activities, known as circadian clock alignment, can aid weight loss and improve health in people with obesity. Participants in the "Circadian Clock Alignment" arm will follow a structured schedule for meals and sleep to align their circadian clock. Research suggests that set times for meals and sleep can enhance weight-loss results after surgery. This method may also improve the body's insulin use, crucial for controlling blood sugar levels. Meanwhile, participants in the "Circadian Clock Control" arm will maintain their usual routines without changes to meal, sleep, or wake times. Additionally, weight-loss surgery itself has proven to lead to significant weight loss and better overall health. Early findings suggest these approaches could help manage obesity and related health issues.13678
Who Is on the Research Team?
Matthew Brady, PhD
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for obese women aged 18-55 with a BMI over 40, scheduled for bariatric surgery at the University of Chicago. It's not open to those allergic to lidocaine, with uncontrolled high blood pressure, recent surgery or clinical study participation, lactating or post-menopausal women, men, beta blocker users, pregnant individuals, or anyone with certain serious illnesses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Surgery Intervention
Participants undergo circadian clock alignment intervention or control conditions 3 nights before bariatric surgery
Bariatric Surgery
Participants undergo bariatric surgery
Post-Surgery Monitoring
Participants are monitored for changes in insulin sensitivity and gene expression in adipocytes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Circadian Clock Alignment
- Circadian Clock Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor