To detect and to compare diabetic biomarker in saliva and blood of Periodontitis patients with and without Type 2 Diabetes Mellitus

Not yet recruiting

Conditions: Type 2 diabetes mellitus with other specified complications,

Registration Number: CTRI/2023/02/049363

Lead Sponsor: Self

Brief Summary: Periodontitis and Diabetes Mellitus (DM) are two chronic inflammatory conditions which share a bidirectional relationship, with diabetes increasing the risk of periodontitis and periodontal inflammation negatively affecting glycemic control. The diagnosis of diabetes in patients with periodontitis is of utmost importance given the role of glycemic control in determining increased risk. Fasting blood sugar (FBS) has been the gold standard diagnostic criterion for Diabetes mellitus and is still the most widely accepted due to its availability, low cost, and compatibility with automated clinical chemistry analyzers. Among the disadvantages of FBS are that it requires at least 8-h fasting, shows substantial biological and diurnal variability, reflects only a single point in time, and the samples involved present stability issues. Furthermore, fasting glucose alone does not give enough information to fully understand the glycemic state of the patient. Also, glycated hemoglobin (HbA1c) concentration cannot measure transitory hyperglycemic changes and is altered by patient characteristics such as medical conditions and ethnicity. A commonly used marker of short-term glycaemic control is 1,5-anhydroglucitol (1,5-AHG). The glycemic biomarker 1,5-AHG is a six-carbon monosaccharide which also is known as 1-deoxyglucose. This biomarker is metabolically stable, originates mainly from the diet (where it is found in low concentrations) and is well absorbed intestinally. Its levels in different biological fluids are stable and correlated with blood glucose. In normoglycemic individuals, about 99.9% of 1,5-AHG is renally absorbed, thus, it is retained in detectable concentrations in blood and saliva. Under hyperglycemia, the glucose transporters are monopolized by the excess glucose. The 1,5-AHG is not reabsorbed at the tubular level, reducing its concentration in serum and saliva. Thus, the levels of 1,5-AHG in serum decreases while glucose levels rise. 1,5-AHG has been previously shown to be present in saliva and was strongly correlated with serum 1,5-AHG and inversely correlated with FBS, PPBS, and HbA1c. Evidence shows that 1,5-AHG has a greater sensitivity than HbA1c as a marker for early detection of abnormal glucose levels and when 1,5-AHG is combined with FBS or HbA1c improved the efficiency of diabetes screening. A study by Liebsch et al in 2019 reported alteration of salivary 1,5-AHG levels in periodontitis and its level was associated with missing teeth count. However, utility of salivary 1,5-AHG as a biomarker has not been established in patients diagnosed with periodontitis and Type 2 diabetes mellitus. Thus, the aim of the present study is to estimate and correlate salivary and serum 1,5-AHG levels in periodontitis patients with and without type 2 diabetes mellitus and to evaluate its utility as a potential diagnostic marker.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Presence of minimum 20 natural teeth.
Group 1 Patients diagnosed with Generalized periodontitis and Type 2 Diabetes Mellitus.
Group 2 Patients diagnosed with Generalized Periodontitis who are normoglycemic.
Group 3 Healthy controls.

Exclusion Criteria

1 Patients with any other systemic disease accompanying Type 2 DM.
2 Patients with Type 1 DM.
3 Patients who are obese (BMI >30) 4 Current or former smokers.
5 Pregnant women.
6 Patients with any intra oral lesions and unrestored caries.
7 Patients with history of periodontal therapy within past 6 months.
9 Patients with history of anti-inflammatory drug therapy within 3 months.
10 Patients taking any others medications excluding medication for DM.
11 Patients taking SGLT-2 inhibitor (SGLT-2i treatment can interfere with the measurement of 1,5-AHG, resulting in a falsely low value in patients with controlled blood glucose levels).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary 1,5-AHG levels	Baseline
PPBS	Baseline
HbA1c	Baseline
Serum 1,5-AHG levels	Baseline
FBS	Baseline

Secondary Outcome Measures

Name	Time	Method
Plaque index	Gingival index

Trial Locations

Locations (1): Vydehi Institute of Dental Sciences and Research Centre
🇮🇳
Bangalore, KARNATAKA, India
Vydehi Institute of Dental Sciences and Research Centre
🇮🇳Bangalore, KARNATAKA, India
Dr Kashmira R
Principal investigator
9751536325
kashmirarajappa@gmail.com