| CTRI Number |
CTRI/2024/07/071563 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Calculated risk score for identifying the complications of type 2 diabetes mellitus |
|
Scientific Title of Study
|
Evaluation between serum uric acid to high-density lipoprotein cholesterol ratio and insulin resistance in type 2 diabetes patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Singh |
| Designation |
Junior Resident |
| Affiliation |
Kasturba medical college |
| Address |
Department of Biochemistry, Kasturba Medical college, tiger circle, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8076130822 |
| Fax |
|
| Email |
drpoojasingh0990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Singh |
| Designation |
Junior Resident |
| Affiliation |
Kasturba medical college |
| Address |
Department of Biochemistry, Kasturba Medical college, tiger circle, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8076130822 |
| Fax |
|
| Email |
drpoojasingh0990@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Singh |
| Designation |
Junior Resident |
| Affiliation |
Kasturba medical college |
| Address |
Department of Biochemistry, Kasturba Medical college, tiger circle, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8076130822 |
| Fax |
|
| Email |
drpoojasingh0990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Karnataka, India- 576104 |
|
|
Primary Sponsor
|
| Name |
Dr. Pooja Singh |
| Address |
Department of Biochemistry, Kasturba Medical College, Manipal, Karnataka, India- 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 krishnananda Prabhu |
Kasturba Medical College |
Department of Biochemistry, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
9844380157
krishnananda.prabhu@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Based on the duration of T2DM, cases will be sub-grouped into a study group with less than 5 years of T2DM and a study group with 5-10 years of T2DM.
CRP values less than 16 mg/L |
|
| ExclusionCriteria |
| Details |
1. Age: less than 20 years and more than 60 years
2. Women with gestational diabetes and pregnant and lactating mothers.
3. Patients with Type 1 diabetes, hyperuricemia patients under medications, thyroid disorders, K/C/O CVD and other major illnesses [HTN, cancer, CKD]
4. T2DM patients with CRP more than16 mg/L |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will be helpful in finding the association between demographical data, FBS, PPBS, HbA1C, SUA, lipid profile, and UHR, which can be used to assess insulin resistance for further managing type 2 diabetes mellitus. Publications will be done in International / National journals with a high impact factor.
|
At the end of the study after patient recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Comorbidities: Assessing the prevalence and impact of other health conditions (e.g., hypertension, cardiovascular diseases, renal function) in patients with type 2 diabetes mellitus. |
In the end of the study |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
15/08/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Type 2 diabetes mellitus (T2DM) is a complex metabolic disorder characterised by insulin resistance (IR) and hyperglycemia, leading to various complications . Long-term complications cause the majority of deaths in patients with T2DM. Currently, 415 million people are affected by this disorder. In particular, the main objective of early diagnosis and treatment of type 2 diabetes is to decrease disease-related risks. Early identification and treatment of the condition are crucial in every way Several variables contribute to the decline in human health, including inflammation and insulin resistance, which specifically impact fat and glucose metabolism in adipose tissue, the liver, and skeletal muscle . Insulin resistance (IR) and dyslipidemia are two pathogenetic variables that are essential to the onset of type 2 diabetes. Some studies say that uric acid is inversely proportional to HbA1c.But some studies have shows that hyperuricemia a predictor of insulin resistance in T2DM. Regarding insulin resistance, HDL-C is an independent contributing factor. The uric acid to HDL-c ratio has recently emerged as a new tool for predicting complications like metabolic disorders. Gulali Aktas et al., concluded that UHR is a promising biomarker to predict diabetic control. More than 10.6% of UHR exhibited an 83% sensitivity and 71% specificity for predicting metabolic syndrome in 100 type 2 diabetes patients, according to retrospective research by Kocak et al. Another study showed that NAFLD was substantially correlated with UHR. UHR may be a factor in the rise in the burden of inflammation. The existing literature supports the association between the serum uric acid to high-density lipoprotein cholesterol ratio and insulin resistance in type 2 diabetes patients. UHR shows promise as a prognostic marker for glycemic status and insulin resistance, providing additional insights into the complex interplay of metabolic factors in T2DM. However, further studies and standardization of measurement techniques are needed to establish UHR’s clinical utility definitively. |