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The Impact of Bariatric Surgery on Adipocyte Metabolism

Primary Purpose

Metabolic Syndrome, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Circadian Clock Alignment
Circadian Clock Control
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring insulin, adipocyte, gene expression

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Circadian Clock Alignment - High BMI

Circadian Clock Control - High BMI

Circadian Clock Control - Low BMI

Arm 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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 23, 2020
Last Updated
May 8, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04242524
Brief Title
The Impact of Bariatric Surgery on Adipocyte Metabolism
Official Title
The Impact of Bariatric Surgery on Adipocyte Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2015 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
Keywords
insulin, adipocyte, gene expression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circadian Clock Alignment - High BMI
Arm Type
Experimental
Arm 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.
Arm Title
Circadian Clock Control - High BMI
Arm Type
Active Comparator
Arm 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.
Arm Title
Circadian Clock Control - Low BMI
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Circadian Clock Alignment
Intervention Description
Use timed lights and meals to align the circadian clock
Intervention Type
Behavioral
Intervention Name(s)
Circadian Clock Control
Intervention Description
No circadian clock alignment
Primary Outcome Measure Information:
Title
Change in insulin sensitivity
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Brady, PhD
Phone
(773) 702-2346
Email
mbrady@bsd.uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Hanlon, PhD
Phone
(773) 834-5849
Email
ehanlon@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Brady, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Brady, PhD
Phone
773-702-2346
Email
mbrady@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Erin Hanlon, PhD
Phone
(773) 834-5849
Email
ehanlon@bsd.uchicago.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Impact of Bariatric Surgery on Adipocyte Metabolism

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