Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04603885
Status:
UNKNOWN
Last Update Posted:
2020-10-27
First Post:
2020-10-21
Brief Title:
Using Polar Unite Fitness Watch 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 mHealth-enhanced Exercise Program to Improve Cognition for T2DM Patients
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_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:
Type 2 diabetes mellitus 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 One critical genetic variant that affects BDNF secretion and cognition is the BDNF Val66Met variant which is a common missense polymorphism that results in a valine Val to methionine Met substitution at codon 66 located in exon IX of the BDNF gene The Met allele alters intracellular processing trafficking packaging of pro-BDNF and consequently interferes with the activity-dependent secretion of mature BDNF among Met carriers In addition previous research reported an influence of the Val66Met variant on the methylation level of the surrounding region Carrying a G nucleotide ie Val allele will have an additional CpG site and ValVal homozygotes demonstrated a significant increase in methylation levels of four nearby CpG sites compared to ValMet heterozygotes and MetMet homozygotes Because high BDNF gene methylation is associated with reduced BDNF mRNA levels this may result in lower BDNF levels among ValVal carriers However the transcription of promoter IV can be initiated by exercise suggesting that epigenetic modulation of BDNF gene expression may be achieved by exercise It is plausible that exercise may partly reverse transcriptional repression through dynamic DNA demethylation but the interaction between DNA demethylation and Val homozygosity may be different from that in MetMet and in ValMet carriers which could explain interpersonal differences in cognitive outcomes among these carriers following exercise training So far the evidence on the interplay of the Val66Met polymorphism DNA methylation and exercise on cognition among individuals with T2DM is still lacking A total of 42 participants with T2DM will be randomized 21 to receive aerobic exercise intervention n28 or attention control n14 for 3 months Both groups will receive weekly phone calls during the intervention and standard printed education materials regarding diabetes self-management In addition to these interventions the aerobic exercise group ie experimental group will also perform home-based walking exercise while the attention control group will perform home-based stretching exercise Trained students will monitor the exercise sessions for both groups at the Connected Health Platform hereafter referred to as platform Blood samples will be collected at baseline and three months Outcomes of interest include post-intervention changes in plasma BDNF levels BDNF DNA methylation executive function memory and processing speed The study will evaluate the feasibility of the home-based exercise intervention The study will also evaluate preliminary effectiveness of the supervised exercise program on of the exercise program on BDNF DNA demethylation An exploratory aim is to explore the association of DNA demethylation with plasma BDNF levels and cognition
Detailed Description:
None
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