Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    17098085 [PUBMED-IDS]

Diabetes and Osteopathic Manipulative Medicine (OMM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663322
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
American Osteopathic Association
Information provided by (Responsible Party):
New York Institute of Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Mellitus Osteopathy in Diseases Classified Elsewhere Procedure: OMT Protocol Procedure: OMT-Sham Protocol Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants and outcomes assessor will be blinded to the arm the participants have been randomly assigned
Primary Purpose: Treatment
Official Title: Diabetes and Osteopathic Manipulative Medicine: A Randomized Controlled Trial
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OMT Protocol
Subjects assigned to this arm will have selected osteopathic manipulative treatment techniques administered during the treatment sessions
Procedure: OMT Protocol
Selected hands-on OMT techniques intended to improve pancreatic function will be administered during the treatment sessions

Sham Comparator: OMT-Sham Protocol
Subjects assigned to this arm will have sham-osteopathic manipulative treatment techniques administered during the treatment sessions
Procedure: OMT-Sham Protocol
Selected hands-on Sham-OMT techniques that are not intended to affect pancreatic function will be administered during the treatment sessions




Primary Outcome Measures :
  1. Fasting glucose [ Time Frame: 3 months ]
    Short term fasting glucose levels


Secondary Outcome Measures :
  1. A1C [ Time Frame: 3 months ]
    Short term A1C levels



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Type II diabetes
  • Able to provide consent for participation
  • Currently taking only oral diabetic medication(s)
  • Prior hemoglobin A1C test result
  • Able to fast for the glucose measurements
  • Able to complete the intake and consent documents

Exclusion Criteria:

  • Insulin dependent diabetes
  • Unable or unwilling to provide informed consent
  • Unable to fast for the glucose measurements
  • Have an absolute contraindication to OMT (i.e. Acute fracture, joint dislocation, an open wound or infection)
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663322


Contacts
Layout table for location contacts
Contact: Sonia Rivera-Martinez, DO 516-686-1418 srmartin@nyit.edu
Contact: Karen Sheflin, DO 516-686-3760 ksheflin@nyit.edu

Locations
Layout table for location information
United States, New York
NYIT Family Health Care Center Recruiting
Central Islip, New York, United States, 11722
Contact: Arline Allera    516-686-7438    aallera@nyit.edu   
Contact: Phyllis Pugliese    516-686-3751    ppuglies@nyit.edu   
Principal Investigator: Sonia Rivera-Martinez, DO         
Sub-Investigator: Karen Sheflin, DO         
NYIT Academic Health Care Center - Riland Bldg. Recruiting
Old Westbury, New York, United States, 11568-
Contact: Arline Allera    516-686-7438    aallera@nyit.edu   
Contact: Phyllis Pugliese    516-686-3751    ppuglies@nyit.edu   
Principal Investigator: Sonia Rivera-Martinez, DO         
Sub-Investigator: Karen Sheflin, DO         
Sub-Investigator: Bhuma Krischnamachari, PhD         
Sub-Investigator: Jayme Mancini, DO         
Principal Investigator: Min-Kyung Jung, PhD         
Sponsors and Collaborators
New York Institute of Technology
American Osteopathic Association
Investigators
Layout table for investigator information
Principal Investigator: Sonia Rivera-Martinez, DO New York Institute of Technology

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT03663322     History of Changes
Other Study ID Numbers: BHS-1383
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will aim to present preliminary findings at poster presentation at American Academy of Osteopathy and American College of Osteopathic Family Medicine conferences and the final results at the American Osteopathic Association (AOA) OMED. The final results will be published in a peer review journal such as the Journal of the American Osteopathic Association or Endocrine Disorders. The authors would offer training of the Type II diabetes OMM treatment protocol utilized in this study as a training workshop at local and national conferences to enable other physicians who practice OMM to use it effectively. NYITCOM would assist in publicizing the research findings via the college's website and through our Public Relations/events coordinator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Six months after the completion of the study
Access Criteria: As determined by the publication journal

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cytarabine
Mitoxantrone
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors