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Impact of Periodontal Disease on Outcomes in Diabetes

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ClinicalTrials.gov Identifier: NCT02289066
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of Nevada, Reno

Brief Summary:
This study examines how periodontal disease affects the complications of diabetes and how treatment for periodontal disease affects biomarkers associated with the complications of diabetes.

Condition or disease
Periodontal Disease Diabetes Mellitus

Detailed Description:

The goal is to look for predictive factors of poor oral health and the impact of poor oral health on the complications of diabetes. The prevalence of periodontal disease among patients with diabetes is higher than in the general population. Periodontal disease is associated with dental loss and increased systemic inflammation which is associated with cardiovascular and bone disease. However, current evidence that treatment of POD will result in improvement of outcomes in patients with diabetes is mixed. Identifying patterns of disease and following biomarkers in patients with diabetes and periodontal disease will answer some of the questions and result in more appropriate recommendations and interventions with reduction in morbidity, mortality and healthcare cost.

This study will be conducted using a cross-sectional design. Investigators will survey 200 consecutive patients with diabetes during routine clinic visits using a questionnaire. Investigators will collect data on demographic information, socio-economic status, oral health status/care, diabetes history (duration, control and complications) and bone health. A subgroup of 24 participants with survey responses suggestive of periodontal disease will be selected to receive treatment for periodontal disease. We will measure their hemoglobin A1c and biomarkers before and after treatment and will compare their levels for changes with treatment. Investigators will analyze collected data using test of proportions, Student's t-test and multivariate regression analyses.


Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Impact of Periodontal Disease on Outcomes in Diabetes
Study Start Date : November 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease




Primary Outcome Measures :
  1. Changes in hemoglobin A1c [ Time Frame: At enrollment, 3 months after enrollment and 6 months after enrollment. ]
  2. biomarkers of inflammation (high sensitivity C - reactive protein and tumor necrosis factor - alpha) [ Time Frame: At enrollment, 3 months after enrollment and 6 months after enrollment. ]
  3. markers of bone turnover (bone specific alkaline phosphatase and C terminal [ Time Frame: At enrollment, 3 months after enrollment and 6 months after enrollment. ]

Secondary Outcome Measures :
  1. Evaluation of the relationship between periodontal disease and diabetes control and complications [ Time Frame: At enrollment only ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
University of Nevada School of Medicine (Las Vegas) Internal medicine and endocrinology clinics
Criteria

Inclusion Criteria:

All patients 18 years or older with diabetes for more than 2 years who present for their regular clinic visit will be eligible for inclusion in the survey part of the study. Further criteria for enrollment into the subgroup (n = 24) will include; Inclusion criteria

  • Answers on the questionnaire suggesting POD or gingivitis.
  • At least 16 teeth in place
  • On a stable treatment for their diabetes
  • Hemoglobin A1c between 6 and 10

Exclusion Criteria:

  • Treatment with anti-inflammatory medications
  • Cigarette smoking
  • Treatment with thiazolidinediones
  • Previous diagnosis of osteoporosis or treatment for osteoporosis with FDA approved agents.

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): NCT02289066


Locations
United States, Nevada
University of Nevada School of Medicine
Las Vegas, Nevada, United States, 89102
Sponsors and Collaborators
University of Nevada, Reno
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Kenneth E Izuora, MD, MBA University of Nevada, Reno

Publications:
1. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.

Responsible Party: University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT02289066     History of Changes
Other Study ID Numbers: 1U54GM104944 ( U.S. NIH Grant/Contract )
1U54GM104944 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Periodontal Diseases
Gingival Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases