The Effects of Chiropractic in Adults With Metabolic Syndrome

Not Applicable

Suspended

• Conditions: Metabolic Syndrome

• Registration Number: NCT05884437
• Lead Sponsor: Life University

Brief 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.

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 Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Start: 2025-01-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-16

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dr. Sid E. Williams Center for Chiropractic Research; 🇺🇸 Marietta, Georgia, United States