Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340321
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-03
First Post:
2024-03-25
Brief Title:
Impact of Metabolic Flexibility on Changes in Metabolic Health
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
Impact of Metabolic Flexibility on Changes in Metabolic Health
Status:
ENROLLING_BY_INVITATION
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:
METPROS
Brief Summary:
Metabolic flexibility is the capacity to adapt fuel oxidation to fuel availability so that ATP synthesis can match its cellular demands Thus for example increases in glucose availability after a meal would increase glucose oxidation while increases in lipid availability during fasting would increase lipid oxidation Enhanced metabolic flexibility has been proposed to protect humans from metabolic diseases Nevertheless most studies examining associations between metabolic flexibility and metabolic health outcomes have used cross-sectional designs Whether impaired metabolic flexibility causes or results from metabolic health impairment is thus unclear
In this study the investigators will use the data from a study conducted approximately 16 years ago in healthy participants without obesity Using the data already collected in that study the metabolic flexibility of each participant will be calculated To test the association between metabolic flexibility and the change in metabolic health the investigators will call back all the participants for a single follow-up visit to reassess several metabolic health outcomes Thus the main aim of the study is to test the association between metabolic flexibility and the change in metabolic health outcomes after 16 years in humans
In this study the investigators will use the data from a study conducted approximately 16 years ago in healthy participants without obesity Using the data already collected in that study the metabolic flexibility of each participant will be calculated To test the association between metabolic flexibility and the change in metabolic health the investigators will call back all the participants for a single follow-up visit to reassess several metabolic health outcomes Thus the main aim of the study is to test the association between metabolic flexibility and the change in metabolic health outcomes after 16 years in humans
Detailed Description:
Metabolic flexibility is the capacity to adapt fuel oxidation to fuel availability so that ATP synthesis can match its cellular demands Thus for example increases in glucose availability after a meal would increase glucose oxidation while increases in lipid availability during fasting would increase lipid oxidation Enhanced metabolic flexibility has been proposed to protect humans from ectopic lipid accumulation and the subsequent development of insulin resistance and metabolic syndrome
In humans metabolic flexibility is assessed by measuring relative macronutrient oxidation ie lipids and carbohydrates in response to metabolic challenges that increase glucose or lipid availability The respiratory exchange ratio RER CO2 production O2 consumption is used to determine relative macronutrient oxidation The euglycemic-hyperinsulinemic clamp is a widely used challenge to assess metabolic flexibility as it increases glucose availability and thus relative glucose oxidation Recently other methods have been proposed to assess metabolic flexibility including the relative lipid oxidation during an overnight fast or the difference between 24-hour RER and sleeping RER in non-exercise energy balance conditions while staying in a metabolic chamber The method most relevant for assessing the influence of metabolic flexibility and its effects on metabolic health outcomes is unknown
The influence of metabolic flexibility on metabolic health outcomes remains uncertain The lack of agreement across studies is explained by the variability in the metabolic challenges differences in the analytical approach to compute metabolic flexibility and the loose use of the metabolic flexibility concept in the context of many different phenomena Moreover most studies examining associations between metabolic flexibility and metabolic health outcomes have used cross-sectional designs Whether impaired metabolic flexibility causes or results from metabolic health impairment is thus unclear Longitudinal studies using well-controlled methods are required to determine the impact of metabolic flexibility on prospective metabolic health
In this pilot and feasibility study the investigators will use the data from a study conducted 16 years ago in 88 healthy participants without obesity InSight study at Pennington Biomedical The study included an euglycemic-hyperinsulinemic clamp an overnight fasting assessment a 24-hour stay in a metabolic chamber and the measurement of metabolic health outcomes Using the data already collected in the InSight study the metabolic flexibility of each participant in the euglycemic-hyperinsulinemic clamp the overnight fast and the metabolic chamber will be calculated To test the association between metabolic flexibilityies and the change in metabolic health outcomes the investigators will call back all the participants for a single follow-up visit to reassess the metabolic health outcomes including body mass index body composition blood pressure HOMA-IR and the circulating concentrations of glucose triglycerides and cholesterol Such data will shed light on the most informative method to assess metabolic flexibility in relationship to specific metabolic health outcomes The investigators will use these preliminary data to design and power future projects to be submitted for funding to scientific federal agencies
Our specific aims are to
1 Test the association between metabolic flexibility in response to a euglycemic-hyperinsulinemic clamp and the change in metabolic health outcomes after 16 years in humans
2 Test the association between metabolic flexibility in response to overnight fasting and the change in metabolic health outcomes after 16 years in humans
3 Test the association between metabolic flexibility in response to a 24-hour stay in a metabolic chamber and the change in metabolic health outcomes after 16 years in humans
In humans metabolic flexibility is assessed by measuring relative macronutrient oxidation ie lipids and carbohydrates in response to metabolic challenges that increase glucose or lipid availability The respiratory exchange ratio RER CO2 production O2 consumption is used to determine relative macronutrient oxidation The euglycemic-hyperinsulinemic clamp is a widely used challenge to assess metabolic flexibility as it increases glucose availability and thus relative glucose oxidation Recently other methods have been proposed to assess metabolic flexibility including the relative lipid oxidation during an overnight fast or the difference between 24-hour RER and sleeping RER in non-exercise energy balance conditions while staying in a metabolic chamber The method most relevant for assessing the influence of metabolic flexibility and its effects on metabolic health outcomes is unknown
The influence of metabolic flexibility on metabolic health outcomes remains uncertain The lack of agreement across studies is explained by the variability in the metabolic challenges differences in the analytical approach to compute metabolic flexibility and the loose use of the metabolic flexibility concept in the context of many different phenomena Moreover most studies examining associations between metabolic flexibility and metabolic health outcomes have used cross-sectional designs Whether impaired metabolic flexibility causes or results from metabolic health impairment is thus unclear Longitudinal studies using well-controlled methods are required to determine the impact of metabolic flexibility on prospective metabolic health
In this pilot and feasibility study the investigators will use the data from a study conducted 16 years ago in 88 healthy participants without obesity InSight study at Pennington Biomedical The study included an euglycemic-hyperinsulinemic clamp an overnight fasting assessment a 24-hour stay in a metabolic chamber and the measurement of metabolic health outcomes Using the data already collected in the InSight study the metabolic flexibility of each participant in the euglycemic-hyperinsulinemic clamp the overnight fast and the metabolic chamber will be calculated To test the association between metabolic flexibilityies and the change in metabolic health outcomes the investigators will call back all the participants for a single follow-up visit to reassess the metabolic health outcomes including body mass index body composition blood pressure HOMA-IR and the circulating concentrations of glucose triglycerides and cholesterol Such data will shed light on the most informative method to assess metabolic flexibility in relationship to specific metabolic health outcomes The investigators will use these preliminary data to design and power future projects to be submitted for funding to scientific federal agencies
Our specific aims are to
1 Test the association between metabolic flexibility in response to a euglycemic-hyperinsulinemic clamp and the change in metabolic health outcomes after 16 years in humans
2 Test the association between metabolic flexibility in response to overnight fasting and the change in metabolic health outcomes after 16 years in humans
3 Test the association between metabolic flexibility in response to a 24-hour stay in a metabolic chamber and the change in metabolic health outcomes after 16 years in humans
Study Oversight
Has Oversight DMC:
None
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?:
None