Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446531
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
Prevention of Progression of Prediabetes Obesity and CV Risk
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Pioneering and Affordable Strategies to Prevent Progression of Prediabetes Obesity and CV Risk in Hispanics
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pre-DM
Brief Summary:
The investigators are studying how to help people with prediabetes Pre-DM and obesity The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight The investigators also want to reduce participants risk of heart problems The study team will look at how these treatments affect metabolism and other body functions to help find new ways to treat diabetes and obesity in the future
Detailed Description:
While taking part in this study participants will be asked to attend approximately 16 visits with the researchers or study staff
Study participants are assigned single-blinded only the study team will know the assigned group to one of 4 study groups receiving a 6-month treatment with Nutritional Consultation either SGLT2 Inhibitor Empagliflozin Rybelsus GLP1 Receptor Agonist Metformin Pioglitazone or placebo A placebo is an inactive harmless substance that looks like the other study drugs This study does not require overnight stays at the hospital in any of the study groups
Duration of the Study will be about 6-7 months
Study participants are assigned single-blinded only the study team will know the assigned group to one of 4 study groups receiving a 6-month treatment with Nutritional Consultation either SGLT2 Inhibitor Empagliflozin Rybelsus GLP1 Receptor Agonist Metformin Pioglitazone or placebo A placebo is an inactive harmless substance that looks like the other study drugs This study does not require overnight stays at the hospital in any of the study groups
Duration of the Study will be about 6-7 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None