| CTRI Number |
CTRI/2023/02/049363 [Registered on: 01/02/2023] Trial Registered Prospectively |
| Last Modified On: |
23/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To detect and to compare diabetic biomarker in saliva and blood of Periodontitis patients with and without Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Estimation and correlation of 1,5-Anhydroglucitol in saliva and serum of Periodontitis patients with and without Type 2 Diabetes Mellitus - A Cross Sectional Analytical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kashmira R |
| Designation |
Post graduate student |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Room no.6, 2nd floor, dental block, 82, Nallurahalli Main road, near BMTC 18th Depot, Vijayanagar, Nallurahalli, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
9751536325 |
| Fax |
|
| Email |
kashmirarajappa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha KJ |
| Designation |
Professor and Head Of the Department |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Room no.6, 2nd floor, Dental block, 82, Nallurahalli Main road, near BMTC 18th Depot, Vijayanagar, Nallurahalli, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
8105490909 |
| Fax |
|
| Email |
nisharejath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha KJ |
| Designation |
Professor and Head Of the Department |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Room no.6, 2nd floor, Dental block, 82, Nallurahalli Main road, near BMTC 18th Depot, Vijayanagar, Nallurahalli, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
8105490909 |
| Fax |
|
| Email |
nisharejath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Roon no.6, 2nd floor, Dental block, Vydehi Institute of Dental Science and Research Centre |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
82, Nallurahalli Main road, near BMTC 18th Depot, Vijayanagar, Nallurahalli, Whitefield, Bengaluru, Karnataka |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kashmira R |
Vydehi Institute of Dental Sciences and Research Centre |
82, Nallurahalli Main road, near BMTC 18th Depot, Vijayanagar, Nallurahalli, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA |
9751536325
kashmirarajappa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institute of Dental Sciences - institutional ethics committee ( VIDS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
8 Patients with history of antibiotic intake within past 3 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). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Salivary 1,5-AHG levels
Serum 1,5-AHG levels
FBS
PPBS
HbA1c |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque index
Gingival index
Bleeding on probing
Probing pocket depth
Clinical attachment loss |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |