The Effects of Chiropractic in Adults With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— MET  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05884437
• Other study ID #: I-0023
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Life University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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]

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: December 31, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Dr. Sid E. Williams Center for Chiropractic Research	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Life University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Length of time needed to recruit target number of participants	through study completion, an average of 1 year
Primary	Participant adherence rate	Proportion of participants able to adhere to the testing & treatment schedule	through study completion, an average of 1 year
Primary	Participant tolerability rate	Proportion of participants able to perform all aspects of the testing regimen	through study completion, an average of 1 year
Primary	Participant retention rate	Proportion of enrolled participants who complete the full testing regimen	through study completion, an average of 1 year
Primary	Acceptability of treatment regimen for participants	9-item acceptability questionnaire	Week 6
Secondary	EEG resting state broadband power	64-channel hydronet cap	Day 1
Secondary	EEG resting state broadband power	64-channel hydronet cap	Week 2
Secondary	EEG resting state broadband power	64-channel hydronet cap	Week 6
Secondary	EEG resting state functional connectivity	64-channel hydronet cap	Day 1
Secondary	EEG resting state functional connectivity	64-channel hydronet cap	Week 2
Secondary	EEG resting state functional connectivity	64-channel hydronet cap	Week 6
Secondary	EEG evoked latency	64-channel hydronet cap during auditory oddball task	Day 1
Secondary	EEG evoked latency	64-channel hydronet cap during auditory oddball task	Week 2
Secondary	EEG evoked latency	64-channel hydronet cap during auditory oddball task	Week 6
Secondary	EEG evoked amplitude	64-channel hydronet cap during auditory oddball task	Day 1
Secondary	EEG evoked amplitude	64-channel hydronet cap during auditory oddball task	Week 2
Secondary	EEG evoked amplitude	64-channel hydronet cap during auditory oddball task	Week 6
Secondary	skin conductance level (SCL)	2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand	Day 1
Secondary	skin conductance level (SCL)	2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand	Week 2
Secondary	skin conductance level (SCL)	2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand	Week 6
Secondary	Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Day 1
Secondary	Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Week 2
Secondary	Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Week 6
Secondary	ECG mean interbeat interval	3 sensors on torso	Day 1
Secondary	ECG mean interbeat interval	3 sensors on torso	Week 2
Secondary	ECG mean interbeat interval	3 sensors on torso	Week 6
Secondary	ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Day 1
Secondary	ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Week 2
Secondary	ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Week 6
Secondary	ECG de-trended fluctuation analysis	3 sensors on torso	Day 1
Secondary	ECG de-trended fluctuation analysis	3 sensors on torso	Week 2
Secondary	ECG de-trended fluctuation analysis	3 sensors on torso	Week 6
Secondary	Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Day 1
Secondary	Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Week 2
Secondary	Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Week 6
Secondary	Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Day 1
Secondary	Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Week 2
Secondary	Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Week 6
Secondary	Electrodermal activity (EDA) power spectral density (PSD)	2 sensors on first and second digits of non-dominant hand	Day 1
Secondary	Electrodermal activity (EDA) power spectral density (PSD)	2 sensors on first and second digits of non-dominant hand	Week 2
Secondary	Electrodermal activity (EDA) power spectral density (PSD)	2 sensors on first and second digits of non-dominant hand	Week 6
Secondary	Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Day 0
Secondary	Composite Autonomic Symptom Score COMPASS-31)	31-item questionnaire	Day 1
Secondary	Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Week 2
Secondary	Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Week 6
Secondary	Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)	8-item questionnaire	Day 0
Secondary	Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)	8-item questionnaire	Day 1
Secondary	Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)	8-item questionnaire	Week 2
Secondary	Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)	8-item questionnaire	Week 6
Secondary	Perceived Stress Scale (PSS)	10-item questionnaire	Day 0
Secondary	Perceived Stress Scale (PSS)	10-item questionnaire	Day 1
Secondary	Perceived Stress Scale (PSS)	10-item questionnaire	Week 2
Secondary	Perceived Stress Scale (PSS)	10-item questionnaire	Week 6