Gestational Diabetes Mellitus, Obesity and Periodontal Disease

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903264
• Other study ID #: BauruSchoolDentistry
• Status: Completed
• Phase: N/A
• First received: September 6, 2016
• Last updated: September 12, 2016
• Start date: January 2007
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Gestational
• Diabetes, Gestational
• Gingival Diseases
• Obesity
• Periodontal Diseases

Intervention

Other:
• Gestational diabetes mellitus

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry	Bauru	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Leukocytosis as an indicator of inflammation	The data was registered in the patient's medical chart.; = 10.000/L	one day	No