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Anti-diabetic agent

Empagliflozin for Obesity-Related Inflammation (SADIE2 Trial)

Phase 1 & 2

Recruiting

Led By Monda Mashayekhi, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 70 years old

Be older than 18 years old

Must not have

Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)

Poorly controlled type 2 diabetes as defined by HbA1c ≥ 9%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial will study if an anti-diabetes drug can reduce inflammation in obese people, which could help prevent heart disease.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects of Empagliflozin may include genital infections in men and women, urinary tract infections, dehydration symptoms like hypotension (low blood pressure), ketoacidosis (high levels of acid in the blood), and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been on long-term steroid treatment for more than a week in the past month.

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My diabetes is not well-managed, with an HbA1c level of 9% or higher.

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I have advanced liver disease with cirrhosis.

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My kidney function, measured by eGFR, is below 45 mL/min/1.73 m2.

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I have had a serious brain condition like a stroke or mini-stroke.

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I have not had a heart attack or serious heart issues in the last 6 months.

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I have a stomach or bowel problem that affects how medicines work in my body.

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I have had pancreatitis or surgery on my pancreas.

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I have taken an SGLT2 inhibitor in the past 3 months.

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I am currently taking blood thinners.

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I understand the details and risks of the study.

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I have a history of immune or blood disorders.

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I have not taken any GLP-1 receptor agonist drugs in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adipose tissue macrophages

Flow mediated dilation

Monocyte chemoattractant protein-1

Secondary study objectives

IL-6

Pro-inflammatory T cells

Trial Design

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.

0 / 14Eligibility criteria met