The Impact of Bariatric Surgery on Adipocyte Metabolism

• Sponsor: University of Chicago (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04242524
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 128.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome; Obesity	Behavioral: Circadian Clock Alignment; Behavioral: Circadian Clock Control	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Impact of Bariatric Surgery on Adipocyte Metabolism
• Actual Study Start Date: Mar 26, 2015
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Circadian Clock Alignment - High BMI 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; Use timed lights and meals to align the circadian clock
Active Comparator: Circadian Clock Control - High BMI 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; No circadian clock alignment
Active Comparator: Circadian Clock Control - Low BMI 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; No circadian clock alignment

Outcome Measures

Primary Outcome Measures

1. Change in insulin sensitivity [12 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

• Principal Investigator: Matthew Brady, PhD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT04242524
• Other Study ID Numbers: IRB14-0984
• First Posted: Jan 27, 2020
• Last Update Posted: Jan 28, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Chicago: insulin; adipocyte; gene expression
• Additional relevant MeSH terms: Metabolic Syndrome

Study Results

No Results Posted as of Jan 28, 2022