Activator and Type II Diabetics

NCT01782092 | Completed

• 1 other identifier: I-009
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Type II Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

• Lowered A1C Levels

  6 months

Study Arms (1)

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

Interventions

Chiropractic Adjustment OTHER

Chiropractic adjustments will be administered using Activator Methods Basic protocol

Chiropractic & Diabetes

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

Life University

Marietta, Georgia, 30060, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 20, 2016

Record last verified: 2015-09

Locations

US (1)