Metabolic SyndromeNCT04242524
The Impact of Bariatric Surgery on Adipocyte Metabolism
A study testing Circadian Clock Alignment in people with Metabolic Syndrome and Obesity, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Circadian Clock Alignment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2015to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- 18-55 years old
Show all 9Show fewer
- Female
- BMI less than 30 kg/m2
- Signed informed consent
Who cannot join
- 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
Show all 21Show fewer
- 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
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Circadian Clock Alignment, Circadian Clock Control
- Keywords
- insulin, adipocyte, gene expression
- Medical subject headings
- Metabolic Syndrome, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Clock AlignmentBehavioural
Use timed lights and meals to align the circadian clock
Circadian Clock ControlBehavioural
No circadian clock alignment
| Study group | Role | What they receive |
|---|---|---|
| Circadian Clock Alignment - High BMI | Experimental | 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. Receives: Behavioral: Circadian Clock Alignment |
| Circadian Clock Control - High BMI | Active comparator | Subjects will not come to the Sleep Lab and will live normally at home with no changes to their meal, sleep or wake times. Receives: Behavioral: Circadian Clock Control |
| Circadian Clock Control - Low BMI | Active comparator | Subjects will not come to the Sleep Lab and will live normally at home with no changes to their meal, sleep or wake times. Receives: Behavioral: Circadian Clock Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start26 Mar 2015
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Brady, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242524
- Sponsor's protocol ID
- IRB14-0984
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2020
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no IRB approval or plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Bariatric Surgery on Adipocyte Metabolism
- ClinicalTrials.gov ID
- NCT04242524
- Acronym / sponsor ID
- IRB14-0984
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- insulin, adipocyte, gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Circadian Clock Alignment - High BMI | Experimental | Behavioral: Circadian Clock AlignmentSubjects 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. |
| Circadian Clock Control - High BMI | Active comparator | Behavioral: Circadian Clock ControlSubjects will not come to the Sleep Lab and will live normally at home with no changes to their meal, sleep or wake times. |
| Circadian Clock Control - Low BMI | Active comparator | Behavioral: Circadian Clock ControlSubjects will not come to the Sleep Lab and will live normally at home with no changes to their meal, sleep or wake times. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circadian Clock AlignmentUse timed lights and meals to align the circadian clock | Behavioural | Circadian Clock Alignment - High BMI |
| Circadian Clock ControlNo circadian clock alignment | Behavioural | Circadian Clock Control - High BMI, Circadian Clock Control - Low BMI |
Primary outcome
Change in insulin sensitivity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No. There is currently no IRB approval or plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Brady, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Clock Alignment in people with Metabolic Syndrome and Obesity, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.