Activator and Type II Diabetics

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Life University
Sponsor:
Information provided by (Responsible Party):
Life University
ClinicalTrials.gov Identifier:
NCT01782092
First received: January 30, 2013
Last updated: May 29, 2014
Last verified: May 2014
  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:


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 2014 (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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Life University:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014