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

January 30, 2013
January 31, 2013
August 2012
August 2013   (final data collection date for primary outcome measure)
Lowered A1C Levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01782092 on ClinicalTrials.gov Archive Site
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Activator and Type II Diabetics
Effect of Activator Methods Technique on Lowering A1c Levels in Type II Diabetics

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).

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Type II Diabetes
Other: Chiropractic Adjustment
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
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August 2013   (final data collection date for primary outcome measure)

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.

Both
30 Years to 60 Years
Yes
Not Provided
United States
 
NCT01782092
I-009
No
Life University
Life University
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Not Provided
Life University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP