Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03663322 |
| Other study ID # |
BHS-1383 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2018 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
April 2022 |
| Source |
New York Institute of Technology |
| Contact |
Sonia Rivera-Martinez, DO |
| Phone |
516-686-1418 |
| Email |
srmartin[@]nyit.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Our research team is proposing a study to investigate the effects of osteopathic manipulative
treatment on the blood sugar levels of persons with Type 2 diabetes. The goal of this study
is to determine if osteopathic manipulative treatment (OMT) can improve the blood sugar
levels of individuals with Type 2 diabetes. Half of the participants will receive osteopathic
manipulative treatment (OMT) and the other will receive OMT-sham treatment.
Description:
The Research Plan
Aims Type II diabetes is a common endocrine disorder of glucose metabolism that is linked to
considerable morbidity and mortality. In the United States, diabetes is a major cause of
cardiovascular disorders including heart disease and stroke. It continues to rise in
prevalence despite the advances made in methods of diabetic glucose control. Diabetes is a
complex chronic disease that involves continuous medical care and self-management strategies.
The main treatment strategies consist of medications and lifestyle modifications. However,
the strategies used in clinical trials while effective are impractical as they are intensive
and expensive to ensure maintaining these treatment strategies over time. A major opportunity
exists for treatment modalities that are affordable and readily implementable such as OMT.
Osteopathic literature suggests that there may be a role for OMT in the treatment of patients
with diabetes mellitus. This is supported by our preliminary data reported below. The OMT
protocol developed for this research study is based on osteopathic literature and geared
towards optimizing bodily function for patients with Type II diabetes and blood-glucose
homeostasis. OMT utilizes manual forces directed to improve physiological function and
homeostasis by reducing localized dysfunctions of the body referred to as somatic
dysfunctions. OMT may be beneficial in reducing blood glucose levels in Type 2 diabetic
individuals. Improving glucose levels in type II diabetics would reduce the morbidities and
complications of this disorder and have a large impact on patients' health outcomes as well
as in healthcare systems worldwide.
Specific Aims: To determine if the OMT protocol outlined in this study will improve glucose
and A1C levels in individuals with Type II diabetes.
1. To investigate whether the use of OMM (osteopathic manipulative medicine) targeting
pancreatic function will decrease blood glucose in diabetic patients after each OMM
treatment (short-term effects)
2. To investigate whether the use of OMM targeting pancreatic function over a 3 month
period will decrease blood glucose in diabetic patients (long-term effects)
3. To investigate whether the use of OMM targeting pancreatic function over a 3 month
period will decrease A1C levels in diabetic patients (long-term effects)
The primary outcome measure for glucose levels will be measured by obtaining pre and post
OMT/OMT-sham glucose levels at each of the 6 treatments sessions delivered every 2 weeks for
3 months. The primary outcome measure for A1C levels will be measured by obtaining blood
samples at time 0, at the end of months 1, 2 and 3. Results will be compared between the OMT
and OMT-sham groups. If the results support the hypotheses, the OMT protocol can be filmed on
video and performed in workshops for other osteopathic physicians to improve glucose control
in their Type II diabetic patients.
Background A comprehensive systematic review of the published osteopathic literature found
little evidence of OMT as part of the management of Type II diabetes. Nevertheless, the few
published articles do provide encouragement for future studies on this topic. A small study,
which was subsequently re-analyzed, suggested that OMT may reduce blood glucose levels and
increase insulin secretion in diabetic patients. In this study 150 diabetic patients had
fasting blood glucose measured and this was followed by provision of OMT targeted to produce
pancreatic stimulation and glucose levels. The patients had glucose measured either 30
minutes and/or 60 minutes after the OMT session. The results obtained revealed a rapid
decrease in the glucose levels of the treated patients. The investigators have obtained
similar results during the course of our care of Type II diabetic patients. A case-control
pilot study found consistent osteopathic palpatory findings in patients with Type II diabetes
as compared to the non-diabetic patients. Other osteopathic literature support the use of OMT
in the treatment of diabetes-related musculoskeletal complications In light of the little
evidence of previously published osteopathic literature and the potentially high impact that
the results would have, the investigators propose to conduct a study to investigate the
possible effects of OMT on glucose and A1C levels in patients with diagnosed Type II diabetes
as compared with an OMT-sham treatment protocol. The goals of this study will be to determine
if OMT is effective in the management of patients with Type II diabetes.
Power analysis/methods:
Power analysis has been performed to estimate an optimal sample size required to achieve at
least 80% of statistical power in the ANCOVA analysis. An effect size as a necessary input
for power analysis was estimated based on the information in the reference that investigated
the effects of an education program with exercise on blood glucose and A1C levels in subjects
with Type 2 diabetes. A total of 90 Type II diabetic subjects is required to detect the
estimated effect size of d=0.6 with a statistical power of 80% and α=0.05. After accounting
for an expected attrition rate of 10%, a total of 100 subjects with Type II diabetes will be
recruited.
The trial will be registered on clinicaltrials.gov. Recruitment will be the primary focus in
the first 3 months of the study. All of the above manners of recruitment will be re-visited
every 3 months until the trial is completed.
Research design and methods Subjects: Participants with diagnosed Type II diabetes will be
randomized into the OMT intervention or OMM-sham cohorts for comparison of the effects of the
OMT protocol on our outcome measures.
Subject population characteristics:
Sample size: 100 Age range: 30-90 years Gender: Male or female Racial/ethnic background: any
Health status: Type II diabetic diagnosed at least 5 years prior to inclusion in this study
Specimens, records, and data: will be collected from individual participants in this study.
Blood glucose and A1C levels will be obtained using a Glucometer and A1C kits and will be
processed and recorded at the time of the visit.
Recruitment Plan:
Subjects will be recruited by direct recruitment from the NYIT Academic Health Care Center
and Family Health Care centers, posting of IRB-approved flyers in local public places,
contact with local endocrinologists to identify interested patients and introduce the study
at local Diabetic disease support groups and symposiums. The NYIT Academic Health Care Center
and Family Health Care Centers in which the investigators see patients provides healthcare
services to over 500 patients with Type II diabetes annually. The investigators will directly
recruit participants for this clinical trial using these recommendations. IRB-approved flyers
will be placed in visible areas of our health centers. The flyer will have the principal
investigators name, office number, and email address for potential participants. The
organizers for local support groups and symposiums for Diabetes will be contacted. The
principal investigator will request to attend the meeting to provide a brief introduction to
the study and recruit participants that may meet the eligibility criteria. Other local
endocrinologists may be called to introduce the study and to request that these specialists
identify any of his/her patients that may be interested in our research.
Consent procedure:
Recruited, eligible subjects will be presented with the consent form and given as much time
to read or have the form read to them as necessary to decide. A faculty investigator will be
present during this process to answer any questions the subject may have. The consent to
their participation in the study using a written form will be obtained by a faculty
investigator.
Potential risks to participants:
Subject may experience minor emotional distress from talking about their medical history or
the structural physical exam. As with all individuals treated with OMT, the subject may
experience soreness after the OMT. The subject may experience discomfort from the blood
glucose testing. The risks associated with fingersticks for the blood glucose and A1C levels
include risk of bleeding, infection, or syncope. Standard precautions during fingerstick
procedures will be followed. Alternatively, subjects may benefit by becoming more aware of
various aspects of their diagnosis.
Protection against risks:
In the case of any adverse effect from this study, Sonia Rivera-Martinez, DO, Karen Sheflin,
DO or Jayme Mancini, DO, PhD, will be contacted about the incident and the subject will cease
any participation in the research study. In addition, the Institutional Review Board (IRB)
will be notified of the adverse effect within 24 business hours. No deception will be used in
this study. If the research should reveal a medical or potentially troubling condition, the
subject will be advised to make an appointment with their primary care physician. Semi-annual
progress reports and annual renewal reports to the NYIT IRB are required for all IRB-approved
protocols. Any adverse effects will be evaluated by the full IRB. Note that this research
protocol will be submitted for IRB approval.
Participation in the study will be entirely voluntary and confidential. In the study, the
subjects will be given a number for blinding purposes. Each subject will be assigned and
given a registration identification that does not contain any content that can identify the
subject. For example, IRB1130_PDC001 will be the subject identification for the first subject
and IRB1130_PDC002 will be for the second subject and so forth. The subject's name, date of
birth or other identifying material will not be included in this file. The subject's number
identity will be secured in the office of the principal investigator on a desktop computer
requiring a login and password for access.
Access to the subject's information will be allowed only by the research team to ensure
confidentiality. The questionnaire and test data will not have patient identification
information and if it is printed out and it will be stored under lock and key in the
principal investigator's office. If it is not printed out, it will be kept on a password
protected on our computer. Since there is no identifying material for each subject file only
the investigators will know which data correlates with which subject. Thus, subject data is
safeguarded in a HIPAA compliant program and is separated from any clinical patient files.
The process of maintaining human research subject confidentiality is practiced by NYITCOM
faculty, staff, and students and monitored by the Assistant Dean of Research and the NYIT
IRB.
Risks to subjects:
The methods utilized in this study are minimal risk and not different than are used in
standard health care. There may or may not be a direct benefit to the subjects during the
study, however, the information taken from the study may benefit the subjects or other people
with Type II diabetes in the future.
Outcome Measures (A) Fasting glucose levels: Each participant will be tested 12 times
throughout the course of their individual participation in the research study. The fasting
glucose levels will be obtained pre-OMT/OMT-sham and 30 minutes post-OMT/OMT-sham treatments
have been completed. Each OMT/OMT-sham session will last 15 minutes and will be scheduled
from (8 AM to 10 AM). Each participant will have a total of 6 treatment sessions which will
be scheduled every 2 weeks. Specific glucometer test kits will be utilized for the purpose of
obtaining the glucose levels. The subjects will be scheduled for the OMT/OMT-sham treatments
at the same time slot for each visit to decrease the likelihood of glucose variability due to
the measurements being taken at different times of the day. (Refer to Appendix A - Protocol
for fasting glucose)
(B) A1C levels: Each participant will be tested 4 times throughout the course of their
individual participation in the research study. The A1C levels will be obtained
pre-OMT/OMT-sham at their 1st visit and at the end of their 2nd, 4th and 6th visits. A1C
levels have an approximate ½ life of 28 days. It is, therefore, reasonable to expect a change
at around this timeframe.
All participants will be scheduled for their first visit, which will include documentation of
meeting eligibility criteria, consenting, and assignment to a cohort, first visit outcome
measures, and first OMT or OMT-sham as assigned. The primary outcome measures of glucose
levels will be assessed at pre and post OMT/OMT-sham at each of their 6 visits which will be
scheduled every 2 weeks for 3 months.
Subjects will be instructed to maintain the same physical activity level, continue their
current diet and avoid changes in these throughout the trial period. Should any change occur
subjects will be advised to inform one of the study investigators. This last is to decrease
the likelihood of variations in glucose levels due to changes in physical activity levels or
dietary changes.
OMT Protocol for Type II Diabetes: Weeks 1-6:
Previous reports suggest that primary areas of the body particularly important for
blood-glucose homeostasis include the autonomic nervous system (parasympathetic innervation
via the vagus nerve, sympathetic innervation of the pancreas and liver and kidneys and
adrenal glands), thoracolumbar diaphragm, abdominal lymphatic system (including mesentery),
and the pancreas, liver, and adrenal glands themselves.
The investigators have selected techniques for the OMT protocol which were used by Dr.
Bandeen in his study in which glucose levels were reduced and those recommended in other
studies for the treatment of Type 2 diabetes. Refer to list below.
1. Suboccipital release
2. Thoracic outlet release
3. Rib raising Left ribs 2-9 right ribs 5-12 and ribless rib raising right L1-2
4. Chapman's points for pancreas and liver
5. Fascial Stretch of the Pancreas in Longitudinal Axis
6. Test and Treatment of Pancreatic Motility
7. Pancreatic Fascial Technique
8. Pancreatic stimulation through angle of ribs 3-5
9. Celiac ganglion inhibition
10. Liver pump
The above techniques are well described in the osteopathic literature. The OMT-Sham protocol
will involve simply placing the hands in the general areas of where the OMT selected OMM
techniques are administered. Each technique will be performed for approximately one minute
each.
All treating physicians will have Board certification by the American Osteopathic Association
(AOA) to perform Osteopathic Manipulative Treatments. There will be 2 physicians who will be
specifically trained to deliver either the OMT or OMT-Sham treatment protocols. This measure
will ensure that the techniques are performed in a uniform manner. Every physician will treat
an approximately equal number of subjects.
The treating physicians will be instructed to execute the OMT and OMT-Sham treatment
techniques in the exact order as listed and described in this proposal. The manipulative
techniques of the OMT protocol are those that have been well described in standard
osteopathic textbooks. The sham treatment protocol for this study was designed to be
analogous to the OMT regimen with respect to the treatment time, areas treated and
positioning of the subjects.
Expectations for the proposed study:
If the OMT protocol is effective in treating Type II diabetic subjects the investigators
expect a reduction in the glucose levels in the short term and long term and a reduction in
the A1C levels over the course of the research study.
Analysis To investigate the primary specific aims, analysis of covariance (ANCOVA) will be
used to compare the changes in the before and after treatment sessions for the OMT and
OMT-sham groups with a statistical power of 80% and α=0.05. Analyses will be conducted using
IBM SPSS Statistics 22.
Potential difficulties and limitations of the proposed procedures and alternative approaches
to testing the hypotheses:
Difficulties associated with this study have been addressed where possible. Variability in
the Type II diabetes histories and their associated symptoms will be addressed by analyzing
their effects on the outcome measures. The high attrition rate associated with the diabetic
participants is addressed by planning to recruit an extra 10% of the expected number needed
for significance. There may be a sampling bias wherein people with Type II diabetes and may
be more likely to pursue treatments at our health centers due to the variety of providers
available and social support.
Time-table The OMT protocol was developed by utilizing the available osteopathic literature
and the testing of the administration of the protocol by PI's on her Type II diabetic
patients. Testing the OMT protocol to prove significant improvements in glucose and A1C
levels function amongst individuals with Type II diabetes in a randomized controlled trial is
necessary. Recruitment efforts will continue until the sample size required for significance
is reached as described in the analysis. Statistical analysis will be calculated every 6
months to determine trends in primary outcome measures and assess any reported side effects.
If risks out-weigh benefits, consider modification of methods or termination. The final
statistical analysis will be done at the completion of the trial.
APPENDIX A - Protocol for Fasting Glucose
Instructions to subjects for fasting blood glucose:
- Do not eat or drink anything but water for eight hours before the appointment in which
the fasting blood glucose measurement will be taken.
- Hold off from taking their diabetes medications until after the research encounter has
been completed.
- Please report immediately to the investigator taking the fasting blood glucose
measurement if the participant has or feels any of the following symptoms at any time
during the research encounter:
- Sweatiness and shakiness
- Weakness
- Confusion
- Irritability
- Pale
- Rapid heart rate
- Uncoordinated
- Excessive fatigue
- Blurry vision
Instructions for research staff, investigators, and physician investigators:
Subject with hypoglycemia: Fasting blood glucose < 70 and/or with any of the above symptoms:
1. Provide patient with a small glass of orange or apple juice or Glucerna shake. Contact a
physician investigator to evaluate the subject. Physician investigator will make the
clinical decision if the patient should be referred to the nearest emergency department
or can be safely discharged to their home.
2. The patient will not have OMT/OMT-sham treatment given at that specific research
encounter
Subject with hyperglycemia: Fasting blood glucose > 300 and/or with any of the above
symptoms:
1. Contact a physician investigator to evaluate the subject. Physician investigator will
make the clinical decision if the patient should have rapid-acting insulin administered
and monitored, or referred to the nearest emergency department or can be safely
discharged to their home.
2. The patient will not have OMT/OMT-sham treatment given at that specific research
encounter
