Impact of Periodontal Disease on Outcomes in Diabetes

NCT02289066 | Completed DMC

• 1 other identifier: 1U54GM104944
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease; Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Changes in hemoglobin A1c

  At enrollment, 3 months after enrollment and 6 months after enrollment.

• biomarkers of inflammation (high sensitivity C - reactive protein and tumor necrosis factor - alpha)

  At enrollment, 3 months after enrollment and 6 months after enrollment.

• markers of bone turnover (bone specific alkaline phosphatase and C terminal

  At enrollment, 3 months after enrollment and 6 months after enrollment.

Secondary Outcomes (1)

• Evaluation of the relationship between periodontal disease and diabetes control and complications

  At enrollment only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University of Nevada School of Medicine (Las Vegas) Internal medicine and endocrinology clinics

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nevada, Reno: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Nevada School of Medicine

Las Vegas, Nevada, 89102, United States

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 20969750 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kenneth E Izuora, MD, MBA

  University of Nevada, Reno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: November 13, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)