Clinical trial NCT04242524: The Impact of Bariatric Surgery on Adipocyte Metabolism
Official title: The Impact of Bariatric Surgery on Adipocyte Metabolism
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Keywords: insulin
adipocyte
gene expression
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Change in insulin sensitivity
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Matthew Brady, PhD
role: PRINCIPAL_INVESTIGATOR
References: