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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01782092
Other study ID # I-009
Secondary ID
Status Completed
Phase N/A
First received January 30, 2013
Last updated April 19, 2016
Start date August 2012
Est. completion date August 2014

Study information

Verified date September 2015
Source Life University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study (15-subject prospective case series) is to examine the effects of the Activator Methods technique on decreasing A1c levels in patients with type II Diabetes Mellitus (aka adult-onset diabetes).


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

- Subjects will be eligible to participate in the study if they are between the ages of 30-60 and are clinically diagnosed with Type II diabetes by their primary care providers or endocrinologists (diagnosis usually based on FPG > 126 mg/dL on two occasions).

- Participants must have been diagnosed for at least one year and currently be under medical supervision for the disease.

- They must also have an A1c measurement above 7%, which indicates less than optimal management of the disease.

Exclusion Criteria:

- The study will exclude pregnant women;

- those with co-morbidities affecting life expectancy (e.g. malignancy, CVD); uncontrolled hypertension (> 150/100 mmHg);

- serious trauma (e.g. MVA) within the previous 12 months;

- diagnosed bleeding/clotting disorders; those currently under chiropractic care or having contraindications to Activator care (e.g. vertebral fracture, infection, active inflammatory arthritis, severe osteoporosis).

The presence of these exclusions will be determined during the history and exam procedures. All female subjects will be asked to take precautions during their participation in the study to avoid becoming pregnant.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Chiropractic Adjustment
Chiropractic adjustments will be administered using Activator Methods Basic protocol

Locations

Country Name City State
United States Life University Marietta 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 Lowered A1C Levels 6 months No
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