The Impact of Bariatric Surgery on Adipocyte Metabolism

NCT04242524 | Completed

• 1 other identifier: IRB14-0984
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome; Obesity

Keywords

insulin; adipocyte; gene expression

Outcome Measures

Primary Outcomes (1)

• Change in insulin sensitivity

  Insulin sensitivity will be measured as the by the phosphorylation level of Akt in adipocytes (fat cells) at baseline and 12 weeks post bariatric surgery

  12 weeks

Study Arms (3)

Circadian Clock Alignment - High BMI

EXPERIMENTAL

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.

Behavioral: Circadian Clock Alignment

Circadian Clock Control - High BMI

ACTIVE COMPARATOR

Subjects will not come to the Sleep Lab and will live normally at home with no changes to their meal, sleep or wake times.

Behavioral: Circadian Clock Control

Circadian Clock Control - Low BMI

ACTIVE COMPARATOR

Subjects will not come to the Sleep Lab and will live normally at home with no changes to their meal, sleep or wake times.

Behavioral: Circadian Clock Control

Interventions

Circadian Clock Control BEHAVIORAL

No circadian clock alignment

Circadian Clock Control - High BMI; Circadian Clock Control - Low BMI

Circadian Clock Alignment BEHAVIORAL

Use timed lights and meals to align the circadian clock

Circadian Clock Alignment - High BMI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Female
• BMI greater than 40 kg/m2
• Scheduled for bariatric surgery at the Center for the Surgical Treatment of Obesity at the University of Chicago
• Signed informed consent

You may not qualify if:

• Male
• Diagnosed with a systemic illnesses, including heart, renal, liver, or malignant disease
• Uncontrolled hypertension (blood pressure greater than 140 mmHg systolic and 90 mmHg diastolic without medication)
• use of beta blockers
• hemoglobin less than 11.5g/dL
• known allergy to lidocaine
• pregnancy
• lactation
• Subjects will not have undergone surgery, donated a unit of blood, or participated in another clinical study within the last 4 weeks prior to consent.
• Post-menopausal
• Non-Obese Subjects
• years old
• Female
• BMI less than 30 kg/m2
• Signed informed consent

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Brady, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: March 26, 2015
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)