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GLP-1 Analogue Therapy for Cardiometabolic Risk in Type 1 Diabetes

Q: Is my profile suitable to partake in this clinical trial?

Qualified individuals with <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a> between 18 to 30 years old can enrol in this medical trial, which has sought out 15 participants.

Q: Is this experiment open to elderly participants aged 80 and above?

This clinical trial is exclusively recruiting patients aged 18-30. Conversely, 387 trials are open for minors and 1529 studies accept participants above the age of 65.

Q: Is it permissible to prescribe T1D treatments for young adults who have a body mass index below 25 kg/m2 according to the FDA?

Our team at Power rates the safety of young adults with T1D and a body mass index below 25kg/m2 as 1, given that this is only in Phase 1 trials. This indicates limited evidence regarding both efficacy and safety.

Q: Is enrollment for this clinical trial still available?

As viewed on clinicaltrials.gov, this medical research is not presently enrolling participants. It was first posted November 1st 2023 and the most recent update occurred October 23rd of that same year. Despite its current status, there are still over two thousand other studies actively seeking patients for participation at this moment in time.

Phase 1

Recruiting

Led By Michelle Van Name, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Diagnosed T1D for at least 12 months and with BMI <25 kg/m2

Male or female, aged 18 to ≤30 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 year

Awards & highlights

Study Summary

This trial aims to better understand how T1D with overweight/obesity can reduce cardiometabolic risk by studying how their bodies respond to GLP-1 analogue therapy.

Who is the study for?

This trial is for young adults aged 18-30 with Type 1 Diabetes who are not overweight, use continuous glucose monitoring, have an HbA1c level ≤10%, and no severe kidney or liver issues. They must be willing to follow the study procedures for its duration and cannot be pregnant, lactating, or planning pregnancy.Check my eligibility

What is being tested?

The study tests how a high-fat meal and insulin affect heart disease risk markers in people with Type 1 Diabetes by using two tests: a Hyperinsulinemic-euglycemic clamp to assess insulin resistance and a High Fat Mixed Meal Tolerance Test to measure fat levels after eating.See study design

What are the potential side effects?

Potential side effects may include discomfort from the testing procedures such as feeling full or bloated after the high-fat meal test, reactions at the infusion site during the clamp procedure, and general discomfort from blood draws.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have had Type 1 Diabetes for over a year and my BMI is under 25.

Select...

I am between 18 and 30 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in VAT/(VAT+SAT) from baseline to 1 year

Change in hepatic insulin resistance from baseline to 1 year

Change in triglycerides from baseline to 1 year

Trial Design

1Treatment groups

Experimental Treatment

Group I: Young adults with T1D who have a body mass index <25 kg/m2Experimental Treatment2 Interventions

Young adults with T1D who have a body mass index <25 kg/m2 will have: abdominal MRI, hyperinsulinemic-euglycemic clamp wtih stable isotope tracer, DEXA scan and a High Fat Mixed Meal Tolerance Test.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyperinsulinemic-euglycemic clamp

2013

N/A

~10

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,546 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,360 Previous Clinical Trials

4,314,837 Total Patients Enrolled

Michelle Van Name, MDPrincipal InvestigatorYale University

1 Previous Clinical Trials

23 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my profile suitable to partake in this clinical trial?

"Qualified individuals with type 1 diabetes between 18 to 30 years old can enrol in this medical trial, which has sought out 15 participants."

Answered by AI

Is this experiment open to elderly participants aged 80 and above?

"This clinical trial is exclusively recruiting patients aged 18-30. Conversely, 387 trials are open for minors and 1529 studies accept participants above the age of 65."

Answered by AI

Is it permissible to prescribe T1D treatments for young adults who have a body mass index below 25 kg/m2 according to the FDA?

"Our team at Power rates the safety of young adults with T1D and a body mass index below 25kg/m2 as 1, given that this is only in Phase 1 trials. This indicates limited evidence regarding both efficacy and safety."

Answered by AI

Is enrollment for this clinical trial still available?

"As viewed on clinicaltrials.gov, this medical research is not presently enrolling participants. It was first posted November 1st 2023 and the most recent update occurred October 23rd of that same year. Despite its current status, there are still over two thousand other studies actively seeking patients for participation at this moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes

2023. "Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06105931.