Obesity, MorbidNCT03868592
Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis
A study testing Gastric sleeve/bariatric surgery in people with Obesity, Morbid, run by Mayo Clinic at 1 site in United States.
Trial summary
It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Gastric sleeve/bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 40 - 50 kg/m2.
- Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery
Who cannot join
- Type 1 or Type 2 Diabetes diagnosis or fasting plasma glucose ≥126 mg/dL
- Active coronary artery disease
- Participation in structured exercise (>2 times per week for 30 minutes or longer)
- Smoking
- Medications known to affect adipose tissue metabolism (e.g., beta blockers, corticosteroids)
- Renal insufficiency (serum creatinine > 1.5mg/dl)
- Chronic active liver disease (Bilirubin > 17mmol/L, AST > 144 IU/L, or ALT>165IU/L)
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 559055
Reich Pamela, 5072556062, reich.pamela@mayo.edu
Michael D Jensen, MD
About this study
It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these questions.
Read the detailed description
The purpose of this study is to determine whether the adipose inflammatory cell and cytokine content in Class III obesity is related to lipolysis insulin resistance and, if so, whether sustained, substantial weight loss one year following bariatric surgery reduces inflammation in parallel with improved insulin regulation of lipolysis
- Conditions
- Obesity, Morbid
- Being tested
- Gastric sleeve/bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric sleeve/bariatric surgeryProcedure or surgery
weight loss
| Study group | Role | What they receive |
|---|---|---|
| Gastric sleeve surgery | Experimental | before and after weight loss from bariatric surgery Receives: Procedure: Gastric sleeve/bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
adipose macrophage content, adipose IL-6 and TNF gene expression
Adipose tissue macrophage content as assessed by immunohistochemistry using stains for CD36, CD14 and CD206 will be done. mRNA expression for IL-6 and TNF will be measured
Measured: Before bariatric surgery and approximately 1 year after surgery
insulin regulation of lipolysis (IC50)
The ability of insulin to suppress FFA palmitate release will be assessed using a 2-step insulin clamp and isotope dilution techniques for palmitate kinetics
Measured: Before bariatric surgery and approximately 1 year after surgery
Secondary outcomes (1)
adipocyte perilipin 1 and HSL and ATGL
These proteins will be measured using capillary Western methods.
Measured: Before bariatric surgery and approximately 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Aug 2019
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Study insulin action and adipose function before and after weight loss from gastric sleeve surgery
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael D. Jensen, Mayo Clinic
- Investigators
- Michael D Jensen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868592
- Sponsor's protocol ID
- 17-005349
- Status last verified
- Feb 2026
- First submitted
- 7 Mar 2019
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis
- ClinicalTrials.gov ID
- NCT03868592
- Acronym / sponsor ID
- 17-005349
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 11 Mar 2019 (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.
It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these questions.
Detailed description
The purpose of this study is to determine whether the adipose inflammatory cell and cytokine content in Class III obesity is related to lipolysis insulin resistance and, if so, whether sustained, substantial weight loss one year following bariatric surgery reduces inflammation in parallel with improved insulin regulation of lipolysis
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study insulin action and adipose function before and after weight loss from gastric sleeve surgery
| Arm | Type | Receives |
|---|---|---|
| Gastric sleeve surgery | Experimental | Procedure: Gastric sleeve/bariatric surgerybefore and after weight loss from bariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 40 - 50 kg/m2.
- Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery
Key exclusion criteria (8 listed)
- Type 1 or Type 2 Diabetes diagnosis or fasting plasma glucose ≥126 mg/dL
- Active coronary artery disease
- Participation in structured exercise (>2 times per week for 30 minutes or longer)
- Smoking
- Medications known to affect adipose tissue metabolism (e.g., beta blockers, corticosteroids)
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 |
|---|---|---|
| Gastric sleeve/bariatric surgeryweight loss | Procedure or surgery | Gastric sleeve surgery |
Primary outcome
adipose macrophage content, adipose IL-6 and TNF gene expression
Time frame: Before bariatric surgery and approximately 1 year after surgery
Adipose tissue macrophage content as assessed by immunohistochemistry using stains for CD36, CD14 and CD206 will be done. mRNA expression for IL-6 and TNF will be measured
insulin regulation of lipolysis (IC50)
Time frame: Before bariatric surgery and approximately 1 year after surgery
The ability of insulin to suppress FFA palmitate release will be assessed using a 2-step insulin clamp and isotope dilution techniques for palmitate kinetics
1 secondary outcome
adipocyte perilipin 1 and HSL and ATGL
Time frame: Before bariatric surgery and approximately 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Michael D Jensen, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric sleeve/bariatric surgery in people with Obesity, Morbid, run by Mayo Clinic 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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adipose macrophage content, adipose IL-6 and TNF gene expression (time frame: Before bariatric surgery and approximately 1 year after surgery). The study lists 2 primary outcomes in all. 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 3 Mar 2026.