ObesityPhase 1/2NCT04907214
SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot
A Phase 1/2 study testing Empagliflozin 25 MG in people with Obesity and Pre-diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Pre-diabetes
- What is being tested?
- Empagliflozin 25 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 8 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years old
- Impaired glucose tolerance (two-hour plasma glucose 140-199 mg/dL) or impaired fasting glucose (100-125mg/dL) or HbA1c 5.7-6.4%
- BMI ≥ 30 kg/M2
- The ability to provide informed consent
Who cannot join
- Criteria Related to Medical Diagnoses/Conditions/Treatments:
- Diabetes type 1 or type 2, as defined by a fasting plasma glucose of 126 mg/dL or greater, a two-hour plasma glucose of 200 mg/dL or greater, HbA1c ≥6.5%, or the use of anti-diabetic medication
- Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control
- Cardiovascular disease such as myocardial infarction within six months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
- Presence of implanted cardiac defibrillator or pacemaker
- History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
Show all 30Show fewer
- History of pancreatitis or pancreatic surgery
- History or presence of immunological or hematological disorders
- Clinically significant gastrointestinal impairment that could interfere with drug absorption
- History of advanced liver disease with cirrhosis
- Individuals with an eGFR<45 mL/min/1.73 m2, where eGFR is determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine is expressed in mg/dL and age in years: eGFR (mL/min/1.73m2)=186 • Scr-1.154 • age-0.203 • (0.742 if female)
- Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
- Treatment with anticoagulants
- Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
- History of alcohol abuse (>14 per week for men and >7 per week for women) or illicit drug use
- Treatment with any investigational drug in the one month preceding the study
- Previous randomization in this trial
- Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study
- Inability to comply with the protocol in the opinion of the principal investigator, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- Criteria Related to Known Adverse Effects of Drug:
- Uncircumcised men or men with history of balanitis
- History of urinary incontinence
- History of recurrent (>3) episodes of vulvovaginitis per year, or severe symptoms
- History of Fournier's gangrene
- History of recurrent (≥3) UTIs per year or pyelonephritis
- History of symptomatic hypotension or conditions predisposing to volume depletion
- Known peripheral vascular disease, neuropathy, history of foot ulcers or lower limb amputations
- Treatment with loop diuretics furosemide, torsemide, bumetanide, ethacrynic acid
- Known or suspected allergy to trial medications, excipients, or related products
- Contraindications to study medications, worded specifically as stated in the product's prescribing information
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: The Effect of SGLT2 Inhibition on Adipose Tissue Inflammation and Endothelial Function Pilot
Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This project will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.
Read the detailed description
This study will be expanded to include another 10 participants. Enrollment will begin July 1, 2023.
- Conditions
- Obesity, Pre-diabetes
- Being tested
- Empagliflozin 25 MG
- Medical subject headings
- Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 MGDrug
Oral empagliflozin daily
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Individuals receive empagliflozin 25mg/day orally for 12 weeks Receives: Drug: Empagliflozin 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months
Pro-inflammatory T helper type 1 cells are quantified using flow cytometry
Measured: Baseline to 12 weeks
Change in Flow-mediated Dilation After 3 Months
Endothelial function quantified using flow-mediated dilation by ultrasound, measuring percentage increase in artery diameter during hyperemia.
Measured: Baseline to 12 weeks
Change in Liver Steatosis at 3 Months
Liver steatosis assessment by transient elastography-controlled attenuation parameter imaging, reported as Controlled Attenuation Parameter (CAP)
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 2 Weeks
Pro-inflammatory T cells are quantified using flow cytometry
Measured: Baseline to 2 weeks
Change in the Plasma Inflammatory Cytokine IL-6 After 3 Months
IL-6 is quantified in plasma samples.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start29 Jul 2021
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mashayekhi, Vanderbilt University Medical Center
- Investigators
- Mona Mashayekhi, MD/PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907214
- Sponsor's protocol ID
- 210907
- Status last verified
- Dec 2023
- First submitted
- 25 May 2021
- Last updated
- 29 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of SGLT2 Inhibition on Adipose Tissue Inflammation and Endothelial Function Pilot
- ClinicalTrials.gov ID
- NCT04907214
- Acronym / sponsor ID
- 210907
- Conditions
- Obesity, Pre-diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Posted 1 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This project will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.
Detailed description
This study will be expanded to include another 10 participants. Enrollment will begin July 1, 2023.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin 25 MGIndividuals receive empagliflozin 25mg/day orally for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 70 years old
- Impaired glucose tolerance (two-hour plasma glucose 140-199 mg/dL) or impaired fasting glucose (100-125mg/dL) or HbA1c 5.7-6.4%
- BMI ≥ 30 kg/M2
- The ability to provide informed consent
Key exclusion criteria (30 listed)
- Diabetes type 1 or type 2, as defined by a fasting plasma glucose of 126 mg/dL or greater, a two-hour plasma glucose of 200 mg/dL or greater, HbA1c ≥6.5%, or the use of anti-diabetic medication
- Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control
- Cardiovascular disease such as myocardial infarction within six months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
- Presence of implanted cardiac defibrillator or pacemaker
- History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
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 |
|---|---|---|
| Empagliflozin 25 MGOral empagliflozin daily | Drug | Empagliflozin |
Primary outcome
Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months
Time frame: Baseline to 12 weeks
Pro-inflammatory T helper type 1 cells are quantified using flow cytometry
Change in Flow-mediated Dilation After 3 Months
Time frame: Baseline to 12 weeks
Endothelial function quantified using flow-mediated dilation by ultrasound, measuring percentage increase in artery diameter during hyperemia.
Change in Liver Steatosis at 3 Months
Time frame: Baseline to 12 weeks
Liver steatosis assessment by transient elastography-controlled attenuation parameter imaging, reported as Controlled Attenuation Parameter (CAP)
2 secondary outcomes
Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 2 Weeks
Time frame: Baseline to 2 weeks
Change in the Plasma Inflammatory Cytokine IL-6 After 3 Months
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Mona Mashayekhi, MD/PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Empagliflozin 25 MG in people with Obesity and Pre-diabetes, run by Vanderbilt University Medical Center 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 4 inclusion and 30 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 29 Dec 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months (time frame: Baseline to 12 weeks). The study lists 3 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 29 Dec 2023.