82 Participants Needed

Bariatric Surgery for Obesity

EH
MB
Overseen ByMatthew Brady, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of the treatment Circadian Clock Alignment, Circadian Clock Control for obesity?

Research suggests that bariatric surgery, which includes changes in circadian clock alignment, can lead to significant weight loss and improve metabolic health by altering eating patterns and reprogramming the body's internal clock, especially in the liver. This indicates that aligning the circadian clock may enhance the benefits of bariatric surgery for obesity.12345

Is bariatric surgery generally safe for humans?

Bariatric surgery is considered the most effective long-term treatment for severe obesity, leading to significant weight loss and improvements in obesity-related health issues. Studies suggest it is generally safe, with no significant negative effects on behavior or core circadian rhythms observed in research involving mice.12346

How does bariatric surgery differ from other treatments for obesity?

Bariatric surgery is unique because it not only restricts food intake and alters digestion but also causes significant changes in hormones that regulate hunger and energy balance, leading to long-term weight loss and improvement in conditions like type 2 diabetes. Unlike other treatments, it combines both restrictive and malabsorptive techniques, which are more effective than purely restrictive methods like gastric banding.7891011

What is the purpose of this trial?

The purpose of this study is to understand how daily rhythms of behavior affect the expression of genes in fat cells, and how these daily cycles affect the way fat cells respond to insulin (a hormone that controls blood sugar levels) before and after bariatric surgery.

Research Team

MB

Matthew Brady, PhD

Principal Investigator

University of Chicago

Eligibility Criteria

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

I am female.
You are not significantly overweight.
You are not considered obese based on your weight and height.
See 6 more

Exclusion Criteria

I have been diagnosed with a disease affecting my heart, kidneys, liver, or cancer.
You are allergic to lidocaine.
My blood pressure is controlled and below 140/90 mmHg without medication.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Intervention

Participants undergo circadian clock alignment intervention or control conditions 3 nights before bariatric surgery

1 week
3 visits (in-person for intervention group)

Bariatric Surgery

Participants undergo bariatric surgery

1 day

Post-Surgery Monitoring

Participants are monitored for changes in insulin sensitivity and gene expression in adipocytes

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Circadian Clock Alignment
  • Circadian Clock Control
Trial Overview The study aims to understand how daily behaviors influence gene expression in fat cells and insulin response before and after bariatric surgery by focusing on circadian clock control and alignment.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Circadian Clock Alignment - High BMIExperimental Treatment1 Intervention
Subjects will come to the Sleep Lab three nights before their bariatric surgery procedure for an intervention that will align their central circadian clock. The intervention includes eating meals and snacks at fixed times and having lights off at a specific time at night and lights on at a specific time in the morning.
Group II: Circadian Clock Control - High BMIActive Control1 Intervention
Subjects will not come to the Sleep Lab and will live normally at home with no changes to their meal, sleep or wake times.
Group III: Circadian Clock Control - Low BMIActive Control1 Intervention
Subjects will not come to the Sleep Lab and will live normally at home with no changes to their meal, sleep or wake times.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

References

Circadian Misalignment Is Negatively Associated with the Anthropometric, Metabolic and Food Intake Outcomes of Bariatric Patients 6 Months After Surgery. [2021]
Restructuring of the male mice peripheral circadian network after bariatric surgery. [2021]
Peripheral circadian misalignment: contributor to systemic insulin resistance and potential intervention to improve bariatric surgical outcomes. [2020]
Evening chronotype associates with obesity in severely obese subjects: interaction with CLOCK 3111T/C. [2018]
Gastric bypass alters diurnal feeding behavior and reprograms the hepatic clock to regulate endogenous glucose flux. [2023]
Influence of CLOCK Gene Variants on Weight Response after Bariatric Surgery. [2022]
Meal patterns after bariatric surgery in mice and rats. [2021]
The neurohormonal regulation of energy intake in relation to bariatric surgery for obesity. [2021]
Enterohormonal changes after digestive adaptation: five-year results of a surgical proposal to treat obesity and associated diseases. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Basic considerations in the treatment of obesity. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Hormone changes affecting energy homeostasis after metabolic surgery. [2010]
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