Recruiting

Osteopathic Manipulative Medicine

Sponsor:

New York Institute of Technology

Code:

NCT03663322

Conditions

Type2 Diabetes Mellitus

Osteopathy in Diseases Classified Elsewhere

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

OMT Protocol

OMT-Sham Protocol

Study Details

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.

Conditions

Type2 Diabetes Mellitus

Osteopathy in Diseases Classified Elsewhere

Study ID

NCT03663322

Start date

Nov 15, 2018

Status verified date

Apr, 2022

Completion date

Feb 28, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OMT Protocol

Subjects assigned to this arm will have selected osteopathic manipulative treatment techniques 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

Interventions

OMT Protocol

Selected hands-on OMT techniques intended to improve pancreatic function will be administered during the treatment sessions

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 measure

  • Fasting glucose [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Sonia Rivera-Martinez, DO

516-686-1418srmartin@nyit.edu

Karen Sheflin, DO

516-686-3760ksheflin@nyit.edu

Locations

NYIT Family Health Care Center

Recruiting

Central Islip, New York, United States, 11722

Contacts

Arline Allera

516-686-7438aallera@nyit.edu

Phyllis Pugliese

516-686-3751ppuglies@nyit.edu

Principal Investigator:

Sonia Rivera-Martinez, DO

NYIT Academic Health Care Center - Riland Bldg.

Recruiting

Old Westbury, New York, United States, 11568-

Contacts

Arline Allera

516-686-7438aallera@nyit.edu

Phyllis Pugliese

516-686-3751ppuglies@nyit.edu

Principal Investigator:

Sonia Rivera-Martinez, DO

More Information

Sponsor

New York Institute of Technology

Last update posted

May 2, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Institute of Technology on 2022-05-02.