Changes in diabetes medications in the Diabetes and Periodontal Therapy Trial and their effect on hemoglobin A1c (HbA1c)

Marie C. Gelato, Elinor Schoenfeld, Wei Hou, Bryan Michalowicz, Elizabeth Seaquist, Thomas Oates, Devjit Tripathy, Steven Engebretson, Leslie Hyman

Research output: Contribution to journalArticle

Abstract

Objective 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 6 months following baseline. Methods 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 3 month 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. Results Baseline medication use was similar between the treatment groups (p > 0.40), as were medication changes between BL- 3 month visits and 3 and 6 month 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). Conclusions 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.

Original languageEnglish (US)
Pages (from-to)21-27
Number of pages7
JournalContemporary Clinical Trials
Volume50
DOIs
StatePublished - Sep 1 2016

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Hemoglobins
Therapeutics
Insulin
Hypoglycemic Agents
Chi-Square Distribution
Group Psychotherapy
Analysis of Variance
Outcome Assessment (Health Care)
Injections

Keywords

  • Diabetes
  • Hemoglobin A1c
  • Medications
  • Monitoring
  • Periodontal therapy

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)

Cite this

Changes in diabetes medications in the Diabetes and Periodontal Therapy Trial and their effect on hemoglobin A1c (HbA1c). / Gelato, Marie C.; Schoenfeld, Elinor; Hou, Wei; Michalowicz, Bryan; Seaquist, Elizabeth; Oates, Thomas; Tripathy, Devjit; Engebretson, Steven; Hyman, Leslie.

In: Contemporary Clinical Trials, Vol. 50, 01.09.2016, p. 21-27.

Research output: Contribution to journalArticle

Gelato, Marie C. ; Schoenfeld, Elinor ; Hou, Wei ; Michalowicz, Bryan ; Seaquist, Elizabeth ; Oates, Thomas ; Tripathy, Devjit ; Engebretson, Steven ; Hyman, Leslie. / Changes in diabetes medications in the Diabetes and Periodontal Therapy Trial and their effect on hemoglobin A1c (HbA1c). In: Contemporary Clinical Trials. 2016 ; Vol. 50. pp. 21-27.
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abstract = "Objective 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 6 months following baseline. Methods 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 3 month 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. Results Baseline medication use was similar between the treatment groups (p > 0.40), as were medication changes between BL- 3 month visits and 3 and 6 month 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). Conclusions 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.",
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N2 - Objective 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 6 months following baseline. Methods 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 3 month 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. Results Baseline medication use was similar between the treatment groups (p > 0.40), as were medication changes between BL- 3 month visits and 3 and 6 month 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). Conclusions 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.

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