The Impact of Bariatric Surgery on Adipocyte Metabolism

The University of Chicago

Status

Active, not recruiting

Conditions

Obesity

Metabolic Syndrome

Treatments

Behavioral: Circadian Clock Control

Behavioral: Circadian Clock Alignment

Study type

Interventional

Funder types

Other

Identifiers

NCT04242524

IRB14-0984

Details and patient eligibility

About

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.

Full description

Bariatric surgery as a means of weight loss has become increasingly popular over the last 10-15 years. In addition to promoting weight loss, bariatric surgery has become increasingly recognized for use in the management of diabetes. Recent studies have indicated that bariatric surgery can result in a marked improvement in insulin sensitivity before long term weight loss is attained. The goal of this project is to delineate the changes in the insulin responsiveness of subcutaneous adipocytes obtained by needle biopsy 2 weeks prior to surgery vs. 12 weeks after bariatric surgery, which could account for improvements in overall insulin sensitivity seen before any long-term sustained weight loss has occurred. The investigators will also examine gene expression in adipocytes (fat cells).

Enrollment

82 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Obese Subjects

Inclusion Criteria:

18-55 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

Exclusion Criteria:

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

Inclusion Criteria:

18-55 years old
Female
BMI less than 30 kg/m2
Signed informed consent

Exclusion Criteria:

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 3 patient groups

Circadian Clock Alignment - High BMI

Experimental group

Description:

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.

Treatment:

Behavioral: Circadian Clock Alignment

Circadian Clock Control - High BMI

Active Comparator group

Description:

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

Treatment:

Behavioral: Circadian Clock Control

Circadian Clock Control - Low BMI

Active Comparator group

Description:

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