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GLP1 Receptor Agonist
Semaglutide for Aging
Phase 4
Waitlist Available
Led By Tiffany M Cortes, 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
Have prediabetes or diabetes
Older than 65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
Study Summary
This trial will study the effects of semaglutide on people with diabetes or obesity, looking at physical function, body composition, and aging.
Who is the study for?
This trial is for older adults over 65 living on their own, with a BMI of 27 or higher and prediabetes or diabetes. It's not open to smokers or those with heart or liver disease.Check my eligibility
What is being tested?
The study tests the effects of Semaglutide, an FDA-approved drug for blood sugar control and weight management, along with lifestyle counseling on physical function, body composition, and aging markers in older adults.See study design
What are the potential side effects?
Semaglutide may cause digestive issues like nausea and constipation, risk of low blood sugar levels especially when combined with other diabetes medications, possible thyroid tumors including cancer (rare), pancreatitis, changes in vision due to diabetic retinopathy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have prediabetes or diabetes.
Select...
I am older than 65.
Select...
I live on my own, not in a care facility.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6 minute walking distance
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Semaglutide and lifestyle interventionExperimental Treatment2 Interventions
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program. They will also be given semaglutide for 20 weeks.
Group II: Lifestyle interventionActive Control1 Intervention
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Counseling
2011
Completed Phase 2
~7440
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,017,043 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,394 Total Patients Enrolled
Tiffany M Cortes, MDPrincipal InvestigatorUT Health San Antonio
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have prediabetes or diabetes.I am older than 65.I have heart disease.I have liver disease.I live on my own, not in a care facility.You are a smoker.You have a body mass index (BMI) of 27 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Semaglutide and lifestyle intervention
- Group 2: Lifestyle intervention
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Prediabetes Patient Testimony for trial: Trial Name: NCT05786521 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to join this clinical research?
"Aspiring participants must be between the ages of 65 and 90, have type 2 diabetes, and there are only up to 20 spots available."
Answered by AI
What potential risks are associated with using Semaglutide in combination with lifestyle modification?
"There is ample evidence to suggest that Semaglutide and lifestyle intervention are safe, as indicated by its score of 3. This Phase 4 trial has already been approved for use in some countries."
Answered by AI
What is the participant count for this experiment?
"Indeed, the data hosted at clinicaltrials.gov confirms that this medical trial is still enrolling patients; it was posted on March 1st of 2023 and most recently updated on March 29th of the same year. There are spaces available for 20 participants in one site."
Answered by AI
Are there any vacancies within the research study at this moment?
"According to clinicaltrials.gov, this medical study is presently recruiting patients. It was initially posted on March 1st 2023, and the most recent edit occured at the end of that month."
Answered by AI
Is the recruitment process open to seniors over eighty-five years old?
"The cut-off age for entry into this medical study is 90 years old, with a lower limit of 65. In comparison to the population aged below 18 (103 clinical trials) there are 1138 studies targeting people over the retirement age bracket."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
UT Health San Antonio
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
What can I expect to happen during the trial?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I have tried to lose weight over the past 10 years and have been unsuccessful.
PatientReceived 1 prior treatment
I've tried numerous different methods of losing weight and have been unsuccessful.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- UT Health San Antonio: < 48 hours
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