The Effects of Chiropractic in Adults With Metabolic Syndrome (MET)

The Effects of Chiropractic Care on the Brain, Autonomic Nervous System, Gait, and Patient Reported Outcomes in Adults With Diagnosed or Suspected Metabolic Syndrome: a Proof-of-concept Trial

The purpose of this study is to assess the feasibility of our study procedures/protocols and to look at the potential effects of chiropractic care on people with metabolic syndrome.

Study Overview

• Status: Suspended
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Procedure: Chiropractic adjustment

Detailed Description

After providing informed consent, individuals will undergo 6 weeks of chiropractic care. Throughout these 6 weeks there will be three assessments (Day 0, Week 2, and Week 6) that each include the following:

1. Seated resting recording
2. Auditory oddball task
3. Isometric hand grip
4. Postural challenge
5. Treadmill walking
6. Patient-reported outcome surveys

Each assessment will consist of the following recordings:

1. Electroencephalography [EEG]
2. Electrodermal activity [EDA]
3. Impedance cardiography [ICG]
4. Electrocardiogram [ECG]

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Marietta, Georgia, United States, 30067
      • Dr. Sid E. Williams Center for Chiropractic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals over the age of 18
• Individuals who can wear an EEG net for 30 minutes
• Individuals who can sit quietly for at least 15 minutes
• Individuals who can walk unassisted for up to 10 minutes
• Individuals who can provide informed consent

• Individuals who meet 3 of the 5 following criteria:

  • Elevated waist circumference (>40 in/102 cm if male and >35 in/88cm if female)
  • Elevated triglycerides (>150 mg/dL) or drug treatment for elevated triglycerides
  • Reduced HDL-cholesterol (<40mg/dL if male and <50 mg/dL if female) or drug treatment to increase HDL-C
  • Elevated blood pressure (>130 mm Hg systolic BP or >85 mm Hg diastolic BP) or drug treatment to reduce blood pressure
  • Elevated fasting glucose (>100 mg/dL) or drug treatment to reduce blood glucose

Exclusion Criteria:

• Individuals with a known disorder resulting in syncope/fainting during postural changes (e.g., POTS, orthostatic hypotension)
• Individuals with impaired function of the dominant hand
• Individuals with malignant hypertension
• Individuals with a known heart condition such as arrhythmia that results in an aberrant ECG recording
• Individuals with any implanted devices (i.e., pacemakers)
• Individuals with brain aneurysms
• Individuals with a history of epilepsy or stroke that would influence EEG readings
• Individuals with a diagnosed externalizing or thought disorder (i.e., anti-social disorder, any major personality disorder such as borderline personality disorder, or schizophrenia)
• Individuals who are on short-acting benzodiazepines which include midazolam & triazolam
• Individuals with any serious injury or surgery to the head or torso, or lower body in the last 6 months
• Individuals with a hearing impairment or hearing aids (due to the auditory stimulus recording being performed)
• Individuals who are currently pregnant
• Individuals with current litigation related to a physical, health-related injury
• Individuals who have been diagnosed with rheumatoid arthritis, osteoporosis or instability of the neck.
• Individuals with moderate to severe pain on a daily basis
• Pain on the day of testing rated greater than 3/10 on a visual analog scale (VAS)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chiropractic; Chiropractic adjustment	Procedure: Chiropractic adjustment; Participants will receive 6 weeks of chiropractic care. The frequency of care will be determined by the field clinician. Participants will have their spine assessed for the presence of vertebral subluxations per their clinician's normal and customary procedures. The adjustment technique(s) utilized by the field clinician will be at their discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Length of time needed to recruit target number of participants	through study completion, an average of 1 year
Participant adherence rate	Proportion of participants able to adhere to the testing & treatment schedule	through study completion, an average of 1 year
Participant tolerability rate	Proportion of participants able to perform all aspects of the testing regimen	through study completion, an average of 1 year
Participant retention rate	Proportion of enrolled participants who complete the full testing regimen	through study completion, an average of 1 year
Acceptability of treatment regimen for participants	9-item acceptability questionnaire	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrodermal activity (EDA) power spectral density (PSD)	2 sensors on first and second digits of non-dominant hand	Day 1
Electrodermal activity (EDA) power spectral density (PSD)	2 sensors on first and second digits of non-dominant hand	Week 2
Electrodermal activity (EDA) power spectral density (PSD)	2 sensors on first and second digits of non-dominant hand	Week 6
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Day 1
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Week 2
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Week 6
Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Day 1
Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Week 2
Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Week 6
Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Day 1
Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Week 2
Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Week 6
ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Day 1
ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Week 2
ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Week 6
ECG de-trended fluctuation analysis	3 sensors on torso	Day 1
ECG de-trended fluctuation analysis	3 sensors on torso	Week 2
ECG de-trended fluctuation analysis	3 sensors on torso	Week 6
EEG resting state broadband power	64-channel hydronet cap	Day 1
EEG resting state broadband power	64-channel hydronet cap	Week 2
EEG resting state broadband power	64-channel hydronet cap	Week 6
EEG resting state functional connectivity	64-channel hydronet cap	Day 1
EEG resting state functional connectivity	64-channel hydronet cap	Week 2
EEG resting state functional connectivity	64-channel hydronet cap	Week 6
EEG evoked latency	64-channel hydronet cap during auditory oddball task	Day 1
EEG evoked latency	64-channel hydronet cap during auditory oddball task	Week 2
EEG evoked latency	64-channel hydronet cap during auditory oddball task	Week 6
EEG evoked amplitude	64-channel hydronet cap during auditory oddball task	Day 1
EEG evoked amplitude	64-channel hydronet cap during auditory oddball task	Week 2
EEG evoked amplitude	64-channel hydronet cap during auditory oddball task	Week 6
skin conductance level (SCL)	2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand	Day 1
skin conductance level (SCL)	2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand	Week 2
skin conductance level (SCL)	2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand	Week 6
ECG mean interbeat interval	3 sensors on torso	Day 1
ECG mean interbeat interval	3 sensors on torso	Week 2
ECG mean interbeat interval	3 sensors on torso	Week 6
Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Day 0
Composite Autonomic Symptom Score COMPASS-31)	31-item questionnaire	Day 1
Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Week 2
Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Week 6
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)	8-item questionnaire	Day 0
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)	8-item questionnaire	Day 1
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)	8-item questionnaire	Week 2
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)	8-item questionnaire	Week 6
Perceived Stress Scale (PSS)	10-item questionnaire	Day 0
Perceived Stress Scale (PSS)	10-item questionnaire	Day 1
Perceived Stress Scale (PSS)	10-item questionnaire	Week 2
Perceived Stress Scale (PSS)	10-item questionnaire	Week 6

Collaborators and Investigators

• Sponsor: Life University
• Investigators: Principal Investigator: Tyson Perez, DC, PhD, Life University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 16, 2025

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Metabolic syndrome; autonomic nervous system; EEG; Spinal manipulation; patient reported outcomes; Chiropractic
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: I-0023

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