Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00401791
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2006-11-17
Brief Title:
ACTIV- Exercise Intervention in Healthy Young Men
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
ACTIVValidation of a Paradigm for the Evaluation of Compounds That Activate Mitochondrial Biogenesis in Skeletal Muscle
Status:
COMPLETED
Status Verified Date:
2016-01
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:
The study is designed to compare muscle energy capacity in men with obesity or diabetes as compared to athletes This study will also enable researchers to determine whether MRS can replace muscle biopsy for this type of assessment
Detailed Description:
Skeletal muscle mitochondrial defects are a sine qua non of insulin resistance in patients with type 2 diabetes mellitus T2DM obese and subjects with family history of T2DM FH Exercise increases mitochondrial capacity whereas lipid infusion or high fat diet decreases genes involved in mitochondrial biogenesis In this study 2 cohorts will be involved Cohort I athletes T2DM and obese and Cohort II healthy with FH or without FH- family history of T2DM This randomized parallel arm clinical trial will consist of 4 periods screening stabilization 3 days baseline for Cohort I and II and exercise period 14 days only for Cohort II The overall objective of the study is to validate a paradigm for the evaluation of compounds and drugs that activate mitochondrial biogenesis in skeletal muscle In Specific Aim 1 we will compare and contrast biopsy and MRS power to detect differences in mitochondrial capacity in 78 subjects athletes N10 FH- N24 FH N24 obese N10 and T2DM N10 In Specific Aim 2 we will compare mitochondrial changes in response to exercise in subjects FH - vs FH subjects In Specific Aim 3 we will determine if HFD impairs mitochondrial changes in response to exercise in FH subjects In Specific Aim 4 we will determine the role of mitochondrial capacity in metabolic flexibility and insulin sensitivity in T2DM obese FH FH- and athlete subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None