74 Participants Needed

Empagliflozin for Obesity-Related Inflammation

(SADIE2 Trial)

MM
Overseen ByMona Mashayekhi, MD
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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 trial 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.

Will I have to stop taking my current medications?

The trial requires that you have not used certain medications recently, like SGLT2 inhibitors in the last 3 months or anti-diabetic medications other than a stable dose of metformin or a sulfonylurea in the last month. If you are on these medications, you may need to stop them before joining the trial.

What data supports the effectiveness of the drug empagliflozin for obesity-related inflammation?

Empagliflozin, also known as Jardiance, has been shown to reduce the risk of cardiovascular death and hospitalization in people with heart failure, and it helps manage blood sugar levels in type 2 diabetes, which can also lead to weight loss and lower blood pressure. These effects suggest it may help with conditions related to obesity, although direct evidence for obesity-related inflammation is not provided.12345

Is empagliflozin generally safe for humans?

Empagliflozin, also known as Jardiance, is generally well-tolerated and has been used safely in people with type 2 diabetes and heart failure. However, it can have side effects, such as fluid deficits, and its safety in other conditions like obesity-related inflammation is still being studied.15678

How does the drug empagliflozin differ from other treatments for obesity-related inflammation?

Empagliflozin is unique because it not only helps reduce blood sugar levels by increasing glucose excretion through urine but also promotes fat browning and reduces inflammation in obesity by activating certain immune cells (M2 macrophages). This dual action on energy metabolism and inflammation makes it different from other treatments.14689

Research Team

MM

Monda Mashayekhi, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for adults aged 18-70 with metabolic syndrome, defined by high blood pressure, elevated triglycerides, low HDL cholesterol, high fasting blood sugar or large waist circumference. Participants must have a BMI ≥ 35 kg/m2 and be planning obesity surgery within the next 90-150 days. Exclusions include alcohol/drug abuse history, pregnancy/breastfeeding without contraception, type 1 diabetes or recent SGLT2 inhibitor use.

Inclusion Criteria

You have three or more of the following: high blood pressure, high triglycerides, low HDL cholesterol, high blood sugar, or a large waist size.
I am between 18 and 70 years old.

Exclusion Criteria

My diabetes is not well-managed, with an HbA1c level of 9% or higher.
I am not pregnant or breastfeeding and use effective birth control or am surgically sterilized.
I have advanced liver disease with cirrhosis.
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SGLT2 inhibitor empagliflozin or placebo for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Empagliflozin
Trial OverviewThe study tests whether Empagliflozin (a drug that lowers blood sugar) can reduce inflammation in fat tissue and improve heart-related functions in obese patients. It's a randomized controlled trial where participants will either receive Empagliflozin or a placebo to compare effects.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Empagliflozin ArmActive Control1 Intervention
Empagliflozin is an FDA-approved SGLT2 inhibitor used for the treatment of type 2 diabetes, with off-label use for diabetic kidney disease and for heart failure with reduced ejection fraction even in those without diabetes. To ensure blinding, empagliflozin will be over-encapsulated in identical gelatin capsules as placebo.
Group II: Placebo ArmPlacebo Group1 Intervention
Placebo consists of gelatin capsules.

Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Jardiance for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
🇺🇸
Approved in United States as Jardiance for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
  • Cardiovascular risk reduction
🇨🇦
Approved in Canada as Jardiance for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
🇯🇵
Approved in Japan as Jardiance for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Findings from Research

Empagliflozin (Jardiance) is now approved for reducing the risk of cardiovascular death and hospitalization in adults with heart failure, even in those without diabetes, highlighting its expanded therapeutic use.
Healthcare providers, including nurses and nurse practitioners, should closely monitor patients for potential adverse effects, particularly fluid deficits, to ensure patient safety during treatment.
Diabetes Drug Now Approved for Heart Failure.Aschenbrenner, DS.[2023]
In the EMPEROR-Reduced study involving over 3700 participants with chronic heart failure and reduced ejection fraction, empagliflozin significantly reduced the risk of hospitalization for heart failure complications (13.2% vs. 18.3% for placebo) over an average of 16 months.
Empagliflozin also showed a lower incidence of serious kidney problems (1.6% vs. 3.1% for placebo), indicating its potential safety and efficacy in managing heart failure, although it was associated with a higher rate of genital tract infections.
Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study.Zannad, F., Macari, S.[2023]
Empagliflozin (Jardiance) is a new medication classified as an SGLT2 inhibitor, specifically designed to help manage blood sugar levels in individuals with type-2 diabetes.
This medication not only aids in lowering blood glucose but also has potential benefits for heart health, making it a promising option for patients with diabetes at risk for cardiovascular issues.
Empagliflozin (Jardiance): A Novel SGLT2 Inhibitor for the Treatment of Type-2 Diabetes.Ndefo, UA., Anidiobi, NO., Basheer, E., et al.[2020]

References

Diabetes Drug Now Approved for Heart Failure. [2023]
Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. [2023]
Empagliflozin (Jardiance): A Novel SGLT2 Inhibitor for the Treatment of Type-2 Diabetes. [2020]
[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]
▼ Empagliflozin, diabetes and outcomes. [2017]
The dual role of empagliflozin: Cardio renal protection in T2DM patients. [2022]
Pharmacokinetics, Safety, and Bioequivalence of Two Empagliflozin Formulations after Single Oral Administration under Fasting and Fed Conditions in Healthy Chinese Subjects: An Open-label Randomized Single-dose Two-sequence, Two-treatment, Two-period Crossover Study. [2021]
SGLT2 inhibitors: new reports. [2019]
Emerging roles of SGLT2 inhibitors in obesity and insulin resistance: Focus on fat browning and macrophage polarization. [2019]