Diabetes Mellitus Clinical Trial
Official title:
Anti Oxidant Enzymes and Total Antioxidant Levels in Diabetes Mellitus Type II Patients and Healthy Individuals With Periodontitis
To evaluate the role of antioxidants - superoxide dismutase, catalase, glutathione and total anti oxidant levels in the serum of chronic periodontitis patients and chronic periodontitis with DM Type II patients, then to compare it with healthy controls, to assess their possible role as biomarkers for chronic periodontitis and the possible systemic effects of periodontitis.
This was a cross sectional study involving 300 subjects ,30-60 years of age. 80% was
calculated as the power of the study and error was set at 5%. The ethical clearance for the
study was obtained from the University central ethics committee. A consent form, was given to
all the subjects, which was explained to them and a written consent was taken before
enrolling them. As per the prepared case history format, case history was taken for all the
subjects who were part of the study The body mass index (BMI) was assessed and subjects who
were overweight & obese, with a BMI above 25 , were not included in the study.7 Of the total
of 300 subjects,100 subjects who did not have any systemic diseases were included in group I
and III, and 100 subjects with diabetes mellitus type II, who were not suffering from any
other systemic diseases were included in group II. The diabetic patients in group II were on
oral medication (Metformin derivatives) and appropriate diet control measures, for a period
of at least one year but not more than five years.
Group I and II patients had chronic generalized severe periodontitis.8 Subjects in group III
were systemically healthy and not suffering from any periodontal disease. A single trained
investigator examined the periodontal status of all the subjects. Any other type of
periodontitis was not included in the study.
Subjects were excluded if they had taken antibiotics any time in the last 4 weeks. Vitamin
and mineral supplement intake and those who underwent periodontal treatment procedures in the
course of the last 6 months were eliminated from the study. Tobacco users, alcoholics,
pregnant as well as lactating women were not included in the study.
Only subjects who had a a RBS score of less than 120 and HbA1c score of less than 7 were
accepted in the study.
Then a periodontal examination was carried out, the status of the periodontal condition was
determined, and the subjects were alloted to the three groups by the single trained
investigator,patient was also referred to a physician to determine the systemic condition.
Following this the patients were allotted to the various groups as per the inclusion
criteria. Patients not fulfilling the various criteria were excluded from the study.
5ml of venous blood was taken from the ante cubital vein from each of the study subjects. The
blood from each of the subjects was centrifuged and then stored at -20°C. The serum samples
were then analysed for the various anti oxidants.
Statistical Analysis Statistical analysis of the data was done using SPSS version 17
software. The comparison of the means of the 2 groups was done using the students 'T' test.
Analysis of variance (ANOVA) two tailed test was used to compare the means of more than 2
groups. HSD tukey test with ANOVA jointly,was used to find means that were significantly
different from one another. 'p' value (level of significance) less than 0.05 was taken to be
statistically significant.
Biochemical Study:
5 ml venous blood which was taken from each study subject was divided into 2 parts. 2 ml of
it was collected in EDTA coated vacutainer tubes and 2 ml in plain tubes. The blood in the
EDTA coated tubes was used to assess GSH & SOD. The blood in the plain tubes was used to
assess the CAT and total antioxidant levels . It was centrifuged and the serum obtained was
stored at - 200C for subsequent analysis Superoxide dismutase, glutathione and catalase were
assessed by u.v double beam spectrophotometer and total anti-oxidant levels by
spectrophotometer.
Total antioxidant capacity of serum was determined by the phosphomolybdenum method . The
estimation of superoxide dismutase enzyme was carried out by Beauchamp and Frodovich method.
The catalase activity was assessed using the Hydrogen Peroxide reduction method and
estimation of glutathione was by the DTNB method.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |