NCT03663322

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

4.1 years

First QC Date

September 5, 2018

Last Update Submit

April 25, 2022

Conditions

Type2 Diabetes MellitusOsteopathy in Diseases Classified Elsewhere

Outcome Measures

Primary Outcomes (1)

  • Fasting glucose

    Short term fasting glucose levels

    3 months

Secondary Outcomes (1)

  • A1C

    3 months

Study Arms (2)

OMT Protocol

EXPERIMENTAL

Subjects assigned to this arm will have selected osteopathic manipulative treatment techniques administered during the treatment sessions

Procedure: OMT Protocol

OMT-Sham Protocol

SHAM COMPARATOR

Subjects assigned to this arm will have sham-osteopathic manipulative treatment techniques administered during the treatment sessions

Procedure: OMT-Sham Protocol

Interventions

OMT ProtocolPROCEDURE

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

OMT Protocol
OMT-Sham ProtocolPROCEDURE

Selected hands-on Sham-OMT techniques that are not intended to affect pancreatic function will be administered during the treatment sessions

OMT-Sham Protocol

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NYIT Family Health Care Center

Central Islip, New York, 11722, United States

RECRUITING

NYIT Academic Health Care Center - Riland Bldg.

Old Westbury, New York, 11568-, United States

RECRUITING

Related Publications (8)

  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

    PMID: 11832527BACKGROUND

  • Lindstrom J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemio K, Hamalainen H, Harkonen P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Paturi M, Sundvall J, Valle TT, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006 Nov 11;368(9548):1673-9. doi: 10.1016/S0140-6736(06)69701-8.

    PMID: 17098085BACKGROUND

  • Licciardone JC. Rediscovering the classic osteopathic literature to advance contemporary patient-oriented research: A new look at diabetes mellitus. Osteopath Med Prim Care. 2008 Jul 21;2:9. doi: 10.1186/1750-4732-2-9.

    PMID: 18644129BACKGROUND

  • Shubrook JH Jr, Johnson AW. An osteopathic approach to type 2 diabetes mellitus. J Am Osteopath Assoc. 2011 Sep;111(9):531-7.

    PMID: 21955532BACKGROUND

  • Johnson AW, Shubrook JH Jr. Role of osteopathic structural diagnosis and osteopathic manipulative treatment for diabetes mellitus and its complications. J Am Osteopath Assoc. 2013 Nov;113(11):829-36. doi: 10.7556/jaoa.2013.058.

    PMID: 24174504BACKGROUND

  • Van Ravenswaay VJ, Hain SJ, Grasso S, Shubrook JH. Effects of Osteopathic Manipulative Treatment on Diabetic Gastroparesis. J Am Osteopath Assoc. 2015 Jul;115(7):452-8. doi: 10.7556/jaoa.2015.091.

    PMID: 26111133BACKGROUND

  • Mendes GF, Nogueira JA, Reis CE, de Meiners MM, Dullius J. Diabetes education program with emphasis on physical exercise in subjects with type 2 diabetes: a community-based quasi-experimental study. J Sports Med Phys Fitness. 2017 Jun;57(6):850-858. doi: 10.23736/S0022-4707.16.06261-7. Epub 2016 May 24.

    PMID: 27215770BACKGROUND

  • Licciardone JC, Fulda KG, Stoll ST, Gamber RG, Cage AC. A case-control study of osteopathic palpatory findings in type 2 diabetes mellitus. Osteopath Med Prim Care. 2007 Feb 8;1:6. doi: 10.1186/1750-4732-1-6.

    PMID: 17371582BACKGROUND

Study Officials

  • Sonia Rivera-Martinez, DO

    New York Institute of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Rivera-Martinez, DO

CONTACT

516-686-1418srmartin@nyit.edu

Karen Sheflin, DO

CONTACT

516-686-3760ksheflin@nyit.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcomes assessor will be blinded to the arm the participants have been randomly assigned
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 10, 2018

Study Start

November 15, 2018

Primary Completion

December 31, 2022

Study Completion

February 28, 2023

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Six months after the completion of the study
Access Criteria
As determined by the publication journal

Locations

US(2)