The Impact of Bariatric Surgery on Adipocyte Metabolism

Obesity Clinical Trial

Official title:

The Impact of Bariatric Surgery on Adipocyte Metabolism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04242524
• Other study ID #: IRB14-0984
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 26, 2015
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity

Intervention

Behavioral:
• Circadian Clock Alignment
Use timed lights and meals to align the circadian clock
• Circadian Clock Control
No circadian clock alignment

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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