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Thiazolidinedione
Treatments for Prediabetes and Obesity (Pre-DM Trial)
Phase 1
Recruiting
Led By Carolina Solis-Herrera, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of childbearing potential (WOCBP) including peri-menopausal women who have a menstrual period within 1 year must practice appropriate, and effective birth control, either implants or pills, or have a vasectomized partner prior to receiving the first dose of study medication
Body weight must be stable (±5 pounds) over the last 3 months
Must not have
Patients currently on one of the selected therapies
Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support within 1 week of screening and during the screening period prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Summary
"This trial is looking at ways to help people with prediabetes and obesity by using new and affordable treatments to lower blood sugar levels, promote weight loss, and reduce the risk of heart problems. The
Who is the study for?
This trial is for individuals with prediabetes and obesity, aiming to prevent the progression of these conditions and reduce cardiovascular risk. The specific eligibility criteria are not provided, but typically participants would need to meet certain health standards.
What is being tested?
The study is testing the effectiveness of several treatments: a placebo (inactive pill), Jardiance (a diabetes medication), Metformin (commonly used for diabetes), Rybelsus Tablet, and Actos in improving blood sugar levels and aiding weight loss.
What are the potential side effects?
Potential side effects may include digestive issues from Metformin, dehydration or low blood pressure from Jardiance, heart failure risk increase from Actos, and possible thyroid tumors from Rybelsus.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using effective birth control or my partner is vasectomized.
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My weight has been stable, within 5 pounds, for the last 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on a specific therapy.
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I've needed strong heart failure treatment within the last week.
Select...
I have received a heart transplant or am on the waiting list for one.
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I have a specific heart condition affecting my heart muscle.
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I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use contraception.
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I was diagnosed with cancer within the last 5 years.
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I do not have major organ diseases or physical limitations that prevent me from completing a study.
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I have serious heart valve problems likely needing surgery soon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hemoglobin A1c Level (HBA1c)
Secondary study objectives
Body Mass Index (BMI)
Left Ventricular Function
Measure of extramyocellular lipids (EMCL)
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: SGLT2 inhibitor GroupExperimental Treatment1 Intervention
Randomization will occur 1:1:1:1 to this SGLT2 inhibitor group
Group II: Metformin with SGLT2 Inhibitor GroupExperimental Treatment2 Interventions
Randomization will occur 1:1:1:1 to this metformin plus SGLT2 inhibitor group
Group III: GLP-1 Receptor Agonist GroupExperimental Treatment1 Intervention
Randomization will occur 1:1:1:1 to this GLP-1 receptor agonist group
Group IV: PlaceboPlacebo Group1 Intervention
Randomization will occur 1:1:1:1 to this placebo group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Actos
2007
Completed Phase 3
~920
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
477 Previous Clinical Trials
92,906 Total Patients Enrolled
Baptist Health Foundation of San AntonioUNKNOWN
Carolina Solis-Herrera, MDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
2 Previous Clinical Trials
40 Total Patients Enrolled