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

August 26, 2024 updated by: Life University

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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: through study completion, an average of 1 year
Length of time needed to recruit target number of participants
through study completion, an average of 1 year
Participant adherence rate
Time Frame: through study completion, an average of 1 year
Proportion of participants able to adhere to the testing & treatment schedule
through study completion, an average of 1 year
Participant tolerability rate
Time Frame: through study completion, an average of 1 year
Proportion of participants able to perform all aspects of the testing regimen
through study completion, an average of 1 year
Participant retention rate
Time Frame: through study completion, an average of 1 year
Proportion of enrolled participants who complete the full testing regimen
through study completion, an average of 1 year
Acceptability of treatment regimen for participants
Time Frame: Week 6
9-item acceptability questionnaire
Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electrodermal activity (EDA) power spectral density (PSD)
Time Frame: Day 1
2 sensors on first and second digits of non-dominant hand
Day 1
Electrodermal activity (EDA) power spectral density (PSD)
Time Frame: Week 2
2 sensors on first and second digits of non-dominant hand
Week 2
Electrodermal activity (EDA) power spectral density (PSD)
Time Frame: Week 6
2 sensors on first and second digits of non-dominant hand
Week 6
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Time Frame: Day 1
2 sensors on first and second digits of non-dominant hand
Day 1
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Time Frame: Week 2
2 sensors on first and second digits of non-dominant hand
Week 2
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Time Frame: Week 6
2 sensors on first and second digits of non-dominant hand
Week 6
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time Frame: Day 1
2 sensors on chest and 2 sensors on back
Day 1
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time Frame: Week 2
2 sensors on chest and 2 sensors on back
Week 2
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time Frame: Week 6
2 sensors on chest and 2 sensors on back
Week 6
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time Frame: Day 1
2 sensors on chest and 2 sensors on back
Day 1
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time Frame: Week 2
2 sensors on chest and 2 sensors on back
Week 2
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time Frame: Week 6
2 sensors on chest and 2 sensors on back
Week 6
ECG respiratory sinus arrhythmia (RSA)
Time Frame: Day 1
3 sensors on torso
Day 1
ECG respiratory sinus arrhythmia (RSA)
Time Frame: Week 2
3 sensors on torso
Week 2
ECG respiratory sinus arrhythmia (RSA)
Time Frame: Week 6
3 sensors on torso
Week 6
ECG de-trended fluctuation analysis
Time Frame: Day 1
3 sensors on torso
Day 1
ECG de-trended fluctuation analysis
Time Frame: Week 2
3 sensors on torso
Week 2
ECG de-trended fluctuation analysis
Time Frame: Week 6
3 sensors on torso
Week 6
EEG resting state broadband power
Time Frame: Day 1
64-channel hydronet cap
Day 1
EEG resting state broadband power
Time Frame: Week 2
64-channel hydronet cap
Week 2
EEG resting state broadband power
Time Frame: Week 6
64-channel hydronet cap
Week 6
EEG resting state functional connectivity
Time Frame: Day 1
64-channel hydronet cap
Day 1
EEG resting state functional connectivity
Time Frame: Week 2
64-channel hydronet cap
Week 2
EEG resting state functional connectivity
Time Frame: Week 6
64-channel hydronet cap
Week 6
EEG evoked latency
Time Frame: Day 1
64-channel hydronet cap during auditory oddball task
Day 1
EEG evoked latency
Time Frame: Week 2
64-channel hydronet cap during auditory oddball task
Week 2
EEG evoked latency
Time Frame: Week 6
64-channel hydronet cap during auditory oddball task
Week 6
EEG evoked amplitude
Time Frame: Day 1
64-channel hydronet cap during auditory oddball task
Day 1
EEG evoked amplitude
Time Frame: Week 2
64-channel hydronet cap during auditory oddball task
Week 2
EEG evoked amplitude
Time Frame: Week 6
64-channel hydronet cap during auditory oddball task
Week 6
skin conductance level (SCL)
Time Frame: Day 1
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
Day 1
skin conductance level (SCL)
Time Frame: Week 2
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
Week 2
skin conductance level (SCL)
Time Frame: Week 6
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
Week 6
ECG mean interbeat interval
Time Frame: Day 1
3 sensors on torso
Day 1
ECG mean interbeat interval
Time Frame: Week 2
3 sensors on torso
Week 2
ECG mean interbeat interval
Time Frame: Week 6
3 sensors on torso
Week 6
Composite Autonomic Symptom Score (COMPASS-31)
Time Frame: Day 0
31-item questionnaire
Day 0
Composite Autonomic Symptom Score COMPASS-31)
Time Frame: Day 1
31-item questionnaire
Day 1
Composite Autonomic Symptom Score (COMPASS-31)
Time Frame: Week 2
31-item questionnaire
Week 2
Composite Autonomic Symptom Score (COMPASS-31)
Time Frame: Week 6
31-item questionnaire
Week 6
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
Time Frame: Day 0
8-item questionnaire
Day 0
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
Time Frame: Day 1
8-item questionnaire
Day 1
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
Time Frame: Week 2
8-item questionnaire
Week 2
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
Time Frame: Week 6
8-item questionnaire
Week 6
Perceived Stress Scale (PSS)
Time Frame: Day 0
10-item questionnaire
Day 0
Perceived Stress Scale (PSS)
Time Frame: Day 1
10-item questionnaire
Day 1
Perceived Stress Scale (PSS)
Time Frame: Week 2
10-item questionnaire
Week 2
Perceived Stress Scale (PSS)
Time Frame: Week 6
10-item questionnaire
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Life University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tyson Perez, DC, PhD, Life University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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