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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

Tracking Information
First Submitted Date October 23, 2014
First Posted Date November 13, 2014
Last Update Posted Date December 2, 2015
Study Start Date November 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2014)
  • Changes in hemoglobin A1c [ Time Frame: At enrollment, 3 months after enrollment and 6 months after enrollment. ]
  • 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. ]
  • markers of bone turnover (bone specific alkaline phosphatase and C terminal [ Time Frame: At enrollment, 3 months after enrollment and 6 months after enrollment. ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02289066 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 7, 2014)
Evaluation of the relationship between periodontal disease and diabetes control and complications [ Time Frame: At enrollment only ]
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Periodontal Disease on Outcomes in Diabetes
Official Title Impact of Periodontal Disease on Outcomes in Diabetes
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population University of Nevada School of Medicine (Las Vegas) Internal medicine and endocrinology clinics
Condition
  • Periodontal Disease
  • Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: November 7, 2014)
250
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02289066
Other Study ID Numbers 1U54GM104944( U.S. NIH Grant/Contract )
1U54GM104944 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Nevada, Reno
Study Sponsor University of Nevada, Reno
Collaborators National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Kenneth E Izuora, MD, MBA University of Nevada, Reno
PRS Account University of Nevada, Reno
Verification Date November 2015