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

Tracking Information
First Received Date ^ICMJE	January 30, 2013
Last Updated Date	January 31, 2013
Start Date ^ICMJE	August 2012
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 31, 2013)	Lowered A1C Levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01782092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Activator and Type II Diabetics
Official Title ^ICMJE	Effect of Activator Methods Technique on Lowering A1c Levels in Type II Diabetics
Brief 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).
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Type II Diabetes
Intervention ^ICMJE	Other: Chiropractic Adjustment
Study Group/Cohort (s)	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. Intervention: Other: Chiropractic Adjustment
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	15
Completion Date	Not Provided
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	30 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01782092
Other Study ID Numbers ^ICMJE	I-009
Has Data Monitoring Committee	No
Responsible Party	Life University
Study Sponsor ^ICMJE	Life University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Life University
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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