Metabolic Syndrome and Fall Risk

Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the MetS are at risk for not only future chronic diseases, but they have a higher prevalence of neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls. Currently there are no effective therapies to prevent or reverse the neuropathy seen in the MetS or to reduced the fall risk in this population. This research project will determine if a tailored balance exercise program will have functional benefits and result in a reduced fall risk in the growing population of patients with the MetS and neuropathy.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Autonomic Neuropathy
• Intervention / Treatment: Behavioral: Balance exercise; Behavioral: Standard care

Detailed Description

Active, not recruiting due to COVID-19

55 participants with evidence of the MetS and autonomic neuropathy will be assessed for fall risk with the Four Square Step Test (FSST), which is a measure of dynamic standing balance. Additional endpoints include the dynamic gait index. Measures of height, weight, and waist circumference will be taken and an oral glucose tolerance test as well as lipids and blood pressure will also be measured. Autonomic function will be measured using cardiac autonomic testing, quantitative sudomotor axon reflex test and tilt table testing. Participants will be randomized into either a standard care group that will receive fall risk education or a targeted balance exercise intervention group. Both groups will meet once a week. The intervention group will receive a 12 week balance program with personalized incremental increases in the amount and difficulty of each maneuver.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• MetS at the time of screening based on the International Diabetes Federation definition
• No risk factors for other causes of neuropathy
• Autonomic neuropathy as defined by the Toronto Diabetic Neuropathy Expert Group 2010/11 consensus criteria
• Age 45-75 years inclusive at the time of screening
• Medically stable at the time of enrollment
• Able to participate in a standing balance exercise program without constant standby monitoring
• Women of childbearing potential must be using an acceptable method of contraception for the duration of their participation in the study
• Willing to accept assignment to either training group
• Willing and able to participate in the assigned intervention program

Exclusion Criteria:

• Pregnant women, prisoners, institutionalized subjects and other at risk subjects
• Etiology of neuropathy other than the MetS
• History of severe medical conditions likely to shorten lifespan or alter ability to participate in the trial
• Severe autonomic neuropathy that restricts daily function and the ability to participate in study interventions
• An inability to understand or cooperate with the procedures of the trial or refusal to sign the informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balance exercise program; Participants will attend weekly group training sessions and will keep an exercise log of home activity during a three month exercise program designed to improve balance. Balance exercises will be performed three times per week in a home-based training program.	Behavioral: Balance exercise; tailored balance exercise program
Active Comparator: standard care; Participants will meet in person on a weekly basis for a general education class regarding health and fall prevention but will not participate in an exercise class.	Behavioral: Standard care; general health education and fall prevention classes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Four Square Step Test (FSST)	A measure of proactive dynamic standing balance. A participant steps over four canes that are laid on the ground at 90 degree angles to each other. The participants stands in one of the squares formed by the canes and they are instructed to step as quickly as possible into each square in a specified sequence.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Gait Index (DGI)	An instrumented DGI will be performed on an instrumented gait mat. The DGI is a measure of functional balance during walking an it assesses an individual's ability to modify balance while walking in the presence of external demands (walking while changing speeds, head turns, stepping over and around obstacles, pivoting, and stair climbing).	12 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Maryland
• Investigators: Principal Investigator: Lindsay A Zilliox, MD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: nervous system diseases; neuropathies; metabolic diseases; peripheral nervous system diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: F1651-W; 1IK2RX001651-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No