Type II DiabetesNCT01782092
Activator and Type II Diabetics
An observational study of Type II Diabetes, run by Life University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- Chiropractic Adjustment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Type II Diabetes
- Being tested
- Chiropractic Adjustment
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic AdjustmentOther
Chiropractic adjustments will be administered using Activator Methods Basic protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chiropractic Adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowered A1C Levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782092
- Sponsor's protocol ID
- I-009
- Status last verified
- Sep 2015
- First submitted
- 30 Jan 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Activator Methods Technique on Lowering A1c Levels in Type II Diabetics
- ClinicalTrials.gov ID
- NCT01782092
- Acronym / sponsor ID
- I-009
- Conditions
- Type II Diabetes
- Keywords
- diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chiropractic & Diabetes | – | Other: Chiropractic AdjustmentAll 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic AdjustmentChiropractic adjustments will be administered using Activator Methods Basic protocol | Other | Chiropractic & Diabetes |
Primary outcome
Lowered A1C Levels
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Diabetes, run by Life University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowered A1C Levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.