Gestational Diabetes Mellitus, Obesity and Periodontal Disease

Gestational Diabetes Mellitus, Obesity and Periodontal Disease: a Cross Sectional Study

This study evaluated the periodontal condition of gestational diabetes mellitus (GDM) patients and a healthy non-pregnant control group. For the GDM group all medical data were recorded, including obesity/insulin resistance indicators.

Study Overview

• Status: Completed
• Conditions: Obesity; Periodontal Diseases; Diabetes Mellitus, Gestational
• Intervention / Treatment: Other: Gestational diabetes mellitus

Detailed Description

Gestational diabetes mellitus is associated to a worse periodontal condition. Many patients with these two diseases are also obese. After delivery, some patients maintain the pre-pregnancy obesity status and this condition is also associated to periodontal disease. The mechanisms involved in the relationship of all these medical and periodontal conditions are not clear.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Bauru, Sao Paulo, Brazil, 17012-901
      • Bauru School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Only female participants

Description

Inclusion Criteria:

• Inclusion criteria for GDM group was pregnant women with diagnosis of GDM based on glucose determination described in a previous study (19) and under medical treatment of an endocrinologist and the presence of at least one tooth per sextant.
• Inclusion criteria for control group were absence of periodontal disease, mean age similar to test group and presence of at least one tooth per sextant.

Exclusion Criteria:

• The exclusion criteria for GDM group were pregnant women without diagnosis of diabetes, age below 18 years or higher than 42 years, and the presence of other systemic diseases.
• In control group, women were excluded if they were pregnant, had diabetes or other systemic disease and age below 18 years or higher than 42 years.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GDM group; Gestational diabetes mellitus patients under treatment of an endocrinologist	Other: Gestational diabetes mellitus
Control; Healthy non-pregnant females

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity	Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 6mm and ≥1 interproximal site with PPD ≥5mm. Moderate periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 4mm or ≥ 2 interproximal sites in different teeth with PPD ≥5mm. Mild periodontitis was defined as ≥ 2 interproximal sites in different teeth with ≥ 3 mm CAL and ≥ 2 interproximal sites in different teeth with ≥ 4 mm PPD or at least 1 site with PPD ≥ 5 mm (20,21). Gingivitis was determined as follows: Subjects were considered healthy if presented PPD ≤3mm/BOP extent scores < 10% and with gingivitis if presented PPD ≤3mm/ BOP extent scores >10%. Prevalence of periodontal disease was the sum of gingivitis, mild, moderate and severe periodontitis.	One day
Obesity measured by a tape and a scale	Obese if: body mass index - BMI ≥ 25 Kg/m2 (weight in kilograms, height in meters) Obese if : waist-to-hip ratio - WHR >0.85 (cm)	one day
Gestational diabetes mellitus diagnosed by an endocrinologist	Diagnosis stablished by a doctor based on glucose determination. The data was registered in the patient's medical chart.	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyslipidemia as an indicator of obesity/insulin resistance	The data was registered in the patient's medical chart. Dyslipidemia = HDL ≤ 35 mg/dL / LDL≥ 100 mg/dL / Total cholesterol ≥200 mg/dL / Triglycerides ≥ 150 mg/dL / VLDL < 30 mg/dL	one day
Leukocytosis as an indicator of inflammation	The data was registered in the patient's medical chart. ≥ 10.000/L	one day

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Carla Damante, PhD, University of Sao Paulo

Publications and helpful links

General Publications

• Xie Y, Xiong X, Elkind-Hirsch KE, Pridjian G, Maney P, Delarosa RL, Buekens P. Prepregnancy obesity and periodontitis among pregnant females with and without gestational diabetes mellitus. J Periodontol. 2014 Jul;85(7):890-8. doi: 10.1902/jop.2013.130502. Epub 2013 Dec 19.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Estimate): September 16, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Obesity; Periodontal Disease; Gestational Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Stomatognathic Diseases; Mouth Diseases; Pregnancy Complications; Diabetes Mellitus; Obesity; Periodontal Diseases; Diabetes, Gestational
• Other Study ID Numbers: BauruSchoolDentistry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO