title: Changes in diabetes medications in the Diabetes and Periodontal Therapy Trial and their effect on hemoglobin A1c (HbA1c).
abstract: Evaluate the effect of medications and medication changes during the Diabetes and Periodontal Therapy Trial (DPTT) on the primary study outcome, namely, change in hemoglobin A1c (HbA1c) at 6months following baseline.
  
  
  
  The DPTT set strict criteria for changes in diabetes medications. Medication change was defined as: change in dose of any 1 oral hypoglycemic agent by more than two-fold, change in dose of insulin of >10% and/or addition or subtraction of an oral hypoglycemic agent, insulin or non-insulin injectable agents. Comparisons between the treatment (non- surgical periodontal therapy) and control (no therapy) groups used t-tests for continuous variables and chi-square tests for categorical variables, including DPTT defined diabetes medication changes between baseline (BL) and 3month visits and 3- and 6-month visits. Changes in HbA1c were compared across the four medication change categories using ANOVA models, overall and for each treatment group separately.
  
  
  
  Baseline medication use was similar between the treatment groups (p>0.40), as were medication changes between BL- 3month visits and 3 and 6month visits (p=0.58). Participants with higher BL HbA1c (>8%) and those taking insulin at BL were more likely to have a change in medication (p=0.03).
  
  
  
  The DPTT had the most rigorous definition of medication changes and medication monitoring of any trial in this field to date. The absence of a significant difference in medication changes between treatment groups may suggest that such changes did not play a role in the negative outcome of the DPTT.
authors.affiliation: Division of Endocrinology, Stony Brook Medicine, HSC T16-027i, Stony Brook, New York 11794-8154, United States. Electronic address: marie.gelato@stonybrookmedicine.edu.
authors.forename: Marie C
authors.initials: MC
authors.lastname: Gelato
authors.affiliation: Department of Preventive Medicine, Stony Brook University, School of Medicine, Stony Brook, NY.
authors.forename: Elinor
authors.initials: E
authors.lastname: Schoenfeld
authors.affiliation: Department of Preventive Medicine, Stony Brook University, School of Medicine, Stony Brook, NY.
authors.forename: Wei
authors.initials: W
authors.lastname: Hou
authors.affiliation: Department of Developmental and Surgical Sciences, University of Minnesota, Minneapolis, MN.
authors.forename: Bryan
authors.initials: B
authors.lastname: Michalowicz
authors.affiliation: Department of Medicine, University of Minnesota, Minneapolis, MN.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Seaquist
authors.affiliation: School of Dentistry, University of Texas at San Antonio, San Antonio, TX.
authors.forename: Thomas
authors.initials: T
authors.lastname: Oates
authors.affiliation: Department of Medicine, University of Texas at San Antonio, San Antonio, TX.
authors.forename: Devjit
authors.initials: D
authors.lastname: Tripathy
authors.affiliation: Department of Periodontology and Implant Dentistry, New York University, New York, NY.
authors.forename: Steven
authors.initials: S
authors.lastname: Engebretson
authors.affiliation: Department of Preventive Medicine, Stony Brook University, School of Medicine, Stony Brook, NY.
authors.forename: Leslie
authors.initials: L
authors.lastname: Hyman
mesh_terms: D000328:Adult; D000368:Aged; D012534:Dental Scaling; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects* / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010510:Periodontal Diseases / Q000628:therapy*; D012107:Research Design; D012959:Socioeconomic Factors
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents
keywords: Diabetes; Hemoglobin A1c; Medications; Monitoring; Periodontal therapy