Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-04 @ 1:32 PM
Study NCT ID:
NCT01911104
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-27
First Post:
2013-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Resistance in Type 2 Diabetes
Sponsor:
AdventHealth Translational Research Institute
Organization:
Study Overview
Official Title:
Investigating the Underlying Mechanisms of Exercise Resistance in Individuals With Type 2 Diabetes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
RESIST
Brief Summary:
The purpose of this study is to collect data to help researchers identify factors that prevent certain individuals from receiving the beneficial effects of exercise.
Detailed Description:
STUDY OBJECTIVES/ENDPOINTS
1. The primary endpoint of the study is the maximal capacity for mitochondrial ATP synthesis measured using 31P magnetic resonance spectroscopy (MRS).
2. The principal secondary endpoint is the relationship between exercise-induced changes in mitochondrial function in vivo and exercise mimetic-induced changes in mitochondrial function in vitro.
3. The principal tertiary endpoint is the relationship between the basal promoter methylation status of key genes involved in fuel metabolism and known to be activated by exercise in skeletal muscle tissue and cells and the exercise-induced response in mitochondrial function.
As exercise has an array of metabolic effects, and we are well positioned with our cutting-edge methodologies here at the Translational Research Institute (TRI), we will also measure whole body insulin sensitivity and metabolic flexibility by hyperinsulinemic-euglycemic clamp, substrate oxidation and energy expenditure in the whole room calorimeter/metabolic chamber and intramyocellular lipid content.
1. The primary endpoint of the study is the maximal capacity for mitochondrial ATP synthesis measured using 31P magnetic resonance spectroscopy (MRS).
2. The principal secondary endpoint is the relationship between exercise-induced changes in mitochondrial function in vivo and exercise mimetic-induced changes in mitochondrial function in vitro.
3. The principal tertiary endpoint is the relationship between the basal promoter methylation status of key genes involved in fuel metabolism and known to be activated by exercise in skeletal muscle tissue and cells and the exercise-induced response in mitochondrial function.
As exercise has an array of metabolic effects, and we are well positioned with our cutting-edge methodologies here at the Translational Research Institute (TRI), we will also measure whole body insulin sensitivity and metabolic flexibility by hyperinsulinemic-euglycemic clamp, substrate oxidation and energy expenditure in the whole room calorimeter/metabolic chamber and intramyocellular lipid content.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 471035 | OTHER | Florida Hospital IRB | View |