Diabetes Mellitus Clinical Trial
Official title:
Impact of Periodontal Disease on Outcomes in Diabetes
Verified date | November 2015 |
Source | University of Nevada, Reno |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | University of Nevada School of Medicine | Las Vegas | Nevada |
Lead Sponsor | Collaborator |
---|---|
University of Nevada, Reno | National Institute of General Medical Sciences (NIGMS) |
United States,
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.
Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010 Oct 22;8:29. doi: 10.1186/1478-7954-8-29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in hemoglobin A1c | At enrollment, 3 months after enrollment and 6 months after enrollment. | No | |
Primary | biomarkers of inflammation (high sensitivity C - reactive protein and tumor necrosis factor - alpha) | At enrollment, 3 months after enrollment and 6 months after enrollment. | No | |
Primary | markers of bone turnover (bone specific alkaline phosphatase and C terminal | At enrollment, 3 months after enrollment and 6 months after enrollment. | No | |
Secondary | Evaluation of the relationship between periodontal disease and diabetes control and complications | At enrollment only | No |
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