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Bariatric Surgery for Obesity

N/A

Waitlist Available

Led By Matthew Brady, PhD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-55 years old

Female

Must not have

Diagnosed with a systemic illness, including heart, renal, liver, or malignant disease

Uncontrolled hypertension (blood pressure greater than 140 mmHg systolic and 90 mmHg diastolic without medication)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will help understand how daily rhythms affect gene expression in fat cells and how those cells respond to insulin before and after weight loss surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While this trial focuses on observation rather than medication side effects per se, potential risks may include typical surgical complications from bariatric procedures such as infection or adverse reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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I am female.

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I am a woman aged 18-55 and not obese.

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I am considered obese based on medical standards.

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My BMI is over 40, indicating I am severely obese.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a disease affecting my heart, kidneys, liver, or cancer.

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My blood pressure is controlled and below 140/90 mmHg without medication.

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I have gone through menopause.

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I am male.

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I am currently taking beta blockers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in insulin sensitivity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 10Eligibility criteria met