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

Life University

Status: Suspended

Conditions: Metabolic Syndrome

Treatments: Procedure: Chiropractic adjustment

Study type: Interventional

Funder types: Other

Identifiers

NCT05884437

I-0023

Details and patient eligibility

About

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.

Full 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]

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Chiropractic

Experimental group

Description:

Chiropractic adjustment

Treatment:

Procedure: Chiropractic adjustment