Clinical trial NCT02903264: Gestational Diabetes Mellitus, Obesity and Periodontal Disease
Official title: Gestational Diabetes Mellitus, Obesity and Periodontal Disease: a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Gestational
Periodontal Diseases
Obesity
Keywords: Gestational Diabetes Mellitus
Obesity
Periodontal Disease
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only female participants

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity
timeFrame: One day
measure: Obesity measured by a tape and a scale
timeFrame: one day
measure: Gestational diabetes mellitus diagnosed by an endocrinologist
timeFrame: one day
Secondary outcomes:
measure: Dyslipidemia as an indicator of obesity/insulin resistance
timeFrame: one day
measure: Leukocytosis as an indicator of inflammation
timeFrame: one day
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Carla Damante, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.