Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411210
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-07
Brief Title:
Obesity Complicating Type 1 Diabetes GLP-1 Analogue Anti-obesity Treatment
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Obesity Complicating Type 1 Diabetes in Young Adults Physiology and Impact of GLP-1 Analogue Anti-obesity Treatment on Cardiometabolic Risk Factors
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
More than 40 of young adults with type 1 diabetes T1D also have overweight or obesity Each of these diagnoses increase the risk of adverse cardiovascular events GLP-1 analogues are anti-obesity medications that are cardioprotective in adults with type 2 diabetes however evaluation of these agents in people with T1D has been limited to glycemic outcomes Investigators aim to study the impact of GLP-1 analogue obesity treatment on markers of cardiometabolic risk in young adults with T1D and obesity
Detailed Description:
This proposal will address critical knowledge gaps of understanding potential salutary effects of GLP-1 analogue anti-obesity treatment with weekly semaglutide 24 mg on cardiometabolic risk factors in young adults with T1D and obesity the group of people with T1D at greatest risk for future cardiovascular disease Investigators aim to examine the impact of 12 months of treatment with weekly semaglutide 24 mg compared to placebo on abdominal adipose tissue distribution glucose metabolism and postprandial atherosclerotic lipoproteins in young people with T1D and obesity
This is a single-center parallel group double-blinded placebo controlled randomized clinical trial After informed consent procedures participants will complete four assessments 1 Abdominal MRI to evaluate abdominal adipose partitioning 2 Euglycemic hyperinsulinemic clamp with isotope tracer enhancement to evaluate gluconeogenesis and glucose glycerol and b-hydroxybutyrate turnover to assess measures of insulin resistance 3 DEXA scan to evaluate total body composition and 4 a High-fat mixed meal tolerance test to evaluate postprandial lipemia After completing these baseline measures participants will be randomized in a 21 ratio to receive weekly injected semaglutide escalated to 24 mg or maximum tolerated dose or placebo to treat obesity for 52 weeks At 52 weeks participants will repeat the baseline tests They will then complete a wean off of study drug up to 4 weeks and 2 weeks of additional monitoring for insulin titration
This is a single-center parallel group double-blinded placebo controlled randomized clinical trial After informed consent procedures participants will complete four assessments 1 Abdominal MRI to evaluate abdominal adipose partitioning 2 Euglycemic hyperinsulinemic clamp with isotope tracer enhancement to evaluate gluconeogenesis and glucose glycerol and b-hydroxybutyrate turnover to assess measures of insulin resistance 3 DEXA scan to evaluate total body composition and 4 a High-fat mixed meal tolerance test to evaluate postprandial lipemia After completing these baseline measures participants will be randomized in a 21 ratio to receive weekly injected semaglutide escalated to 24 mg or maximum tolerated dose or placebo to treat obesity for 52 weeks At 52 weeks participants will repeat the baseline tests They will then complete a wean off of study drug up to 4 weeks and 2 weeks of additional monitoring for insulin titration
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK134398-01A1 | NIH | None | httpsreporternihgovquickSearch1R01DK134398-01A1 |