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SGLT2 Inhibitor
SGLT2 Inhibitor for Weight Loss Maintenance in Obesity
Phase 2
Waitlist Available
Led By Pankaj Arora, MD, FAHA
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial aims to help obese people lose weight and keep it off by using a medication that increases their resting energy expenditure.
Who is the study for?
This trial is for adults over 18 with obesity (BMI ≥30 kg/m2) who've lost at least 5% body weight in the past 6 months without using weight loss drugs. It's not for those on certain medications, with cardiovascular diseases, uncontrolled blood pressure, liver issues, severe kidney disease, anemia, type I diabetes, heavy alcohol use, smokers or those with significant psychiatric illnesses.Check my eligibility
What is being tested?
The study tests if Empagliflozin (a drug that blocks sugar reabsorption in kidneys) helps maintain weight loss by increasing resting energy expenditure. Participants are divided into two groups: one receiving Empagliflozin and another as a control group possibly given a placebo or no intervention.See study design
What are the potential side effects?
Empagliflozin may cause urinary tract infections due to increased sugar in urine attracting bacteria; dehydration because of frequent urination; low blood sugar if combined with other diabetes medication; and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Resting Energy Expenditure
Secondary outcome measures
Change in Body Mass Index
Change in Body Weight
Change in CRP
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Empagliflozin ArmExperimental Treatment3 Interventions
Investigator will enroll 12 obese participants who have intentionally lost greater than or equal to 5% of body weight through a non-pharmacological structured weight loss program based on diet and exercise within the last 6 months. The participants will take empagliflozin 25mg/day orally for 12 months.
Group II: Placebo ArmPlacebo Group3 Interventions
Investigator will enroll 12 obese participants who have intentionally lost greater than or equal to 5% of body weight through a non-pharmacological structured weight loss program based on diet and exercise within the last 6 months. The participants will take a placebo pill orally once a day for 12 months.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,638 Total Patients Enrolled
16 Trials studying Weight Loss
102,737 Patients Enrolled for Weight Loss
Pankaj Arora, MD, FAHAPrincipal InvestigatorUniversity of Alabama at Birmingham
5 Previous Clinical Trials
1,260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a BMI of 30 or higher and lost 5% of my weight in the last 6 months without using weight loss drugs.I have smoked within the last year.I have a history of lung disease.I have Type I Diabetes.I am under 18 years old.I am not pregnant, breastfeeding, and I use effective birth control or practice abstinence.I have no known allergies or adverse reactions to empagliflozin.I am 18 years old or older.My kidney function is reduced, with a GFR under 60 and high protein in my urine.I have a history of heart disease, stroke, diabetes, or seizures.I am on medication for weight loss or taking drugs that cause weight loss.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: Empagliflozin Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation include elderly individuals as participants?
"This research is recruiting participants that are of legal age and under the cap of 80 years old."
Answered by AI
Are patients still able to register for this investigation?
"Reported on clinicaltrials.gov, this particular trial has ceased recruitment activities since its last update from May 22nd 2023. Despite that, 1149 other studies are now actively looking for participants to join their trials."
Answered by AI
Am I eligible to partake in this medical research?
"To be accepted for this clinical trial, patients must have lost weight and fall between the ages 18 to 80. 24 participants will eventually partake in the study."
Answered by AI
Is Empagliflozin Arm a hazard to individuals?
"With limited clinical data advocating for its efficacy but some supporting safety, Empagliflozin Arm has been assigned a score of 2."
Answered by AI
Who else is applying?
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I have tried dieting, need help losing the last 25 pounds. Ive had tried bontril and phentermine and super lipo injections. None have worked.
PatientReceived 1 prior treatment
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