Activator and Type II Diabetics

This study is currently recruiting participants.

Verified January 2013 by Life University

Sponsor:

Information provided by (Responsible Party):

Life University

ClinicalTrials.gov Identifier:

NCT01782092

First received: January 30, 2013

Last updated: January 31, 2013

Last verified: January 2013

History of Changes

Purpose

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).

Condition	Intervention
Type II Diabetes	Other: Chiropractic Adjustment

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Effect of Activator Methods Technique on Lowering A1c Levels in Type II Diabetics

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Life University:

Primary Outcome Measures:

Lowered A1C Levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	August 2012
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Chiropractic & Diabetes All subjects will also receive chiropractic care and receive spinal adjustments as indicated by Basic and Intermediate Activator Methods Protocols, which uses a combination of provocative tests designed to elicit a relative change in leg length in the presence of subluxation. Special shoes designed for improved accuracy of leg length analysis will be used for all visits. The patients will be analyzed two times per week for the first month followed by once per week for the remainder of the study. The Activator Methods protocol will be followed for all visits by all doctors in accordance with the guidelines set forth by Activator Methods International, Ltd. The first four visits will be limited to Basic Protocol to allow the patients to become accustomed to the process.	Other: Chiropractic Adjustment

Groups/Cohorts

Assigned Interventions

Chiropractic & Diabetes

All subjects will also receive chiropractic care and receive spinal adjustments as indicated by Basic and Intermediate Activator Methods Protocols, which uses a combination of provocative tests designed to elicit a relative change in leg length in the presence of subluxation. Special shoes designed for improved accuracy of leg length analysis will be used for all visits. The patients will be analyzed two times per week for the first month followed by once per week for the remainder of the study. The Activator Methods protocol will be followed for all visits by all doctors in accordance with the guidelines set forth by Activator Methods International, Ltd. The first four visits will be limited to Basic Protocol to allow the patients to become accustomed to the process.

Other: Chiropractic Adjustment

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782092

Locations

United States, Georgia
Life University	Recruiting
Marietta, Georgia, United States, 30060
Contact: Stephanie Sullivan, DC 770-426-2632 stephanie.sullivan@life.edu
Principal Investigator: Katrina Mayes, DC

Sponsors and Collaborators

Life University

More Information

No publications provided

Responsible Party:	Life University
ClinicalTrials.gov Identifier:	NCT01782092 History of Changes
Other Study ID Numbers:	I-009
Study First Received:	January 30, 2013
Last Updated:	January 31, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Life University:

diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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