Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04590833
Status:
UNKNOWN
Last Update Posted:
2022-01-24
First Post:
2020-10-09
Brief Title:
Feasibility Testing an Exercise Program to Improve Cognition for T2DM Patients
Sponsor:
University of Arkansas Fayetteville
Organization:
University of Arkansas Fayetteville
Study Overview
Official Title:
Feasibility Testing a Randomized Controlled Trial of an Exercise Program to Improve Cognition for T2DM Patients
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
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:
This proposed study will advance science by providing evidence on the feasibility of a standardized rigorously designed and delivered exercise program to improve cognition and plasma brain-derived neurotrophic factor BDNF levels for individuals with type 2 diabetes We will also explore how certain genetic variant may influence exercise-induced cognitive improvements and plasma BDNF levels Findings of the proposed study will establish a comprehensive knowledge base for future research and development of a personalized exercise program for high-risk individuals who are vulnerable to cognitive dysfunction based on their genomic profiles
Detailed Description:
The study will pilot-test a 3-month supervised exercise program to improve plasma brain-derived neurotrophic factor BDNF levels and domains of cognition that are mostly affected in type 2 diabetes mellitus T2DM including memory processing speed and executive function overall and according to genotypes of the BDNF Val66Met variant T2DM impairs the brain leading to cognitive dysfunction which carries substantial lifetime consequences This highlights an urgent need to find effective therapeutic strategies to improve cognitive function among those with T2DM Aerobic exercise enhances cognitive function among healthy subjects through increased release of BDNF BDNF supports survival of existing neurons and promotes growth of new neurons and synapses Emerging evidence suggests that reduced BDNF levels may exacerbate cognitive dysfunction associated with T2DM Compared to drug delivery of BDNF aerobic exercise is a low- cost safe and easily accessible path to increasing endogenous BDNF levels In persons with T2DM integrity of the blood-brain barrier BBB is impaired Although a growing body of evidence supports the protective role of regular exercise in BBB integrity very little is known about how resting peripheral BDNF levels may change in response to regular aerobic exercise training after adjusting for BBB permeability among individuals with T2DM One critical genetic variant that affects cognition in human is the BDNF Val66Met variant The Met allele interferes with the activity-dependent secretion of mature BDNF among Met carriers Despite the strong evidence suggesting aerobic exercise has a beneficial effect on cognitive function significant variability in individual response to exercise training in cognitive outcomes has been reported among ValVal vs Met carriers However the evidence on how the BDNF Val66Met variant influences cognitive outcomes following an aerobic exercise intervention among individuals with T2DM is currently lacking A total of 84 participants with T2DM will be randomized 21 to receive aerobic exercise intervention n56 or attention control n28 for 3 months The study will evaluate the feasibility of the intervention The study will also evaluate preliminary effectiveness of the supervised exercise program on cognitive function and plasma BDNF levels after controlling BBB permeability An exploratory aim is to explore the influence of the BDNF Val66Met polymorphism on cognitive outcomes and plasma BDNF levels in response to aerobic exercise intervention The purpose of this study is well aligned with the National Institute of Nursing Research NINR mission to develop personalized interventions that address mechanisms underlying symptoms of illness through symptom science research Based on the findings of this proposed study our long-term goal is to develop a personalized exercise program for high-risk individuals susceptible to cognitive dysfunction based on their genomic profiles
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