The Effects of Chiropractic in Adults With Metabolic Syndrome

NCT05884437 | Suspended

• 1 other identifier: I-0023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Chiropractic; Metabolic syndrome; Spinal manipulation; autonomic nervous system; EEG; patient reported outcomes

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (48)

• EEG resting state broadband power

  Day 1

• EEG resting state broadband power

  Week 2

• EEG resting state broadband power

  Week 6

• EEG resting state functional connectivity

  Day 1

• EEG resting state functional connectivity

  Week 2

Study Arms (1)

Chiropractic

EXPERIMENTAL

Chiropractic adjustment

Procedure: Chiropractic adjustment

Interventions

Chiropractic adjustment PROCEDURE

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.

Chiropractic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, 30067, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Tyson Perez, DC, PhD

  Life University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm pilot

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: June 1, 2023
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 16, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)