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CTRI Number  CTRI/2022/02/040316 [Registered on: 15/02/2022] Trial Registered Prospectively
Last Modified On: 03/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study to determine the relative level of insulin resistance and defect in insulin secretion in diabetic patients of different body habitus. 
Scientific Title of Study   Comparison of Beta cell dysfunction and Insulin resistance among recently detected type 2 Diabetic patients of different BMI categories using HOMA2 model. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SARIN S M 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Govt Medical College Kannur, Kerala 
Address  DEPT OF MEDICINE GOVT MEDICAL COLLEGE KANNUR PARIYARAM

Kannur
KERALA
670503
India 
Phone    
Fax    
Email  sarinsm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SARIN S M 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Govt Medical College Kannur, Kerala 
Address  DEPT OF MEDICINE GOVT MEDICAL COLLEGE KANNUR PARIYARAM

Kannur
KERALA
670503
India 
Phone    
Fax    
Email  sarinsm@gmail.com  
 
Details of Contact Person
Public Query  
Name  SARIN S M 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Govt Medical College Kannur, Kerala 
Address  DEPT OF MEDICINE GOVT MEDICAL COLLEGE KANNUR PARIYARAM

Kannur
KERALA
670503
India 
Phone    
Fax    
Email  sarinsm@gmail.com  
 
Source of Monetary or Material Support  
Govt Medical College Kannur, Pariyaram 
 
Primary Sponsor  
Name  Dr Sarin S M 
Address  ASSOCIATE PROFESSOR DEPT OF MEDICINE GOVT MEDICAL COLLEGE KANNUR PARIYARAM 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarin S M  Govt medical college kannur, pariyaram  Dept of Medicine
Kannur
KERALA 		 8129312762

sarinsm@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethics committee, Govt Medical college kannur  Approved 
Institutional ethics committee, Govt Medical College Kannur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Recent detected (<5yrs duration) Type 2 Diabetic patients diagnosed based on ADA 2010 criteria in the age group >30 years in Kannur District, Kerala.
 
 
ExclusionCriteria 
Details  1)Patients having Chronic Kidney Disease with GFR<60ml/min/1.73m2
2)Patients diagnosed with Chronic liver disease, chronic Infections and Malignancy.
3)Patients who are using insulin for treatment.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Body mass index
2)Beta cell dysfunction(calculated as HOMA-%B) and insulin resistance (calculated as HOMA-IR) 		 1)Body mass index - baseline
2)Beta cell dysfunction(calculated as HOMA-%B) and insulin resistance (calculated as HOMA-IR) - baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Waist circumference
Waist Hip ratio
Prevalence of Lean, normal body weight and overweight among type 2 DM 		 Baseline 
 
Target Sample Size   Total Sample Size="850"
Sample Size from India="850" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="829" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/02/2022 
Date of Study Completion (India) 31/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Introduction: Obesity and insulin resistance is the cornerstone of pathogenesis in type 2 Diabetes Mellitu patients. Many studies have identified a large section of patients who are not adhering to this expected body habitus and has normal or even lean body weight with associated type 2 diabetes. It has been proposed that such patients might be having increased level of insulin secretory defect early in disease progression compared to overweight phenotype. This study intends to find out the relative beta cell dysfunction and insulin resistance in lean, normal body weight and overweight body types among recently detected type 2 diabetic patients using HOMA2 model. 
Methodology: Crossectional observational study in which recently detected (<5yrs duration) type 2 diabetic patients diagnosed based on ADA 2010 criteria in the age group >30 years is selected from NCD clinic of FHCs in Kannur district, Kerala. Patients will be recruited by cluster sampling technique and data collected from them using prevalidated questionnaire after informed consent. Patients are categorised into lean, normal body weight and overweight patients based on BMI. From each of these groups 35 patients [sample size calculation n = (Zα/2+Zβ)2 *2*σ2 / d2] are randomly selected and their coupled fasting blood sugar, fasting insulin level estimated. Using these values respective insulin resistance(HOMA-IR) and beta cell function(HOMA-%B) will be calculated by the updated Homeostatic Model Assessment (HOMA2). 
Analysis: The descriptive data will be represented using frequency, percentage, mean and standard deviation. Three subgroups namely lean body weight, normal body weight and overweight will be compared for their relative beta cell secretory defect and insulin resistance using ANOVA.

 
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