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CTRI Number  CTRI/2019/09/021398 [Registered on: 24/09/2019] Trial Registered Prospectively
Last Modified On: 24/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   OCCURRENCE OF METABOLIC SYNDROME IN TYPE II DIABETES MELLITUS PATIENTS 
Scientific Title of Study   A STUDY ON ASSESSMENT OF METABOLIC SYNDROME IN TYPE II DIABETES MELLITUS PATIENTS 
Trial Acronym  AMSIDM 
Secondary IDs if Any  
Secondary ID  Identifier 
NGSMIPS/IEC/05/2019-20  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MERLIT JAMES 
Designation  PG STUDENT 
Affiliation  NGSMIPS 
Address  NGSMIPS NITTE deemed to be university deralakatte mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone    
Fax    
Email  mmbean995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr TREESA P VARGHESE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  NGSMIPS 
Address  NGSMIPS NITTE deemed to be university deralakatte mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone    
Fax    
Email  treesapv510@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MERLIT JAMES 
Designation  PG STUDENT 
Affiliation  NGSMIPS 
Address  NGSMIPS NITTE deemed to be university deralakatte mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone    
Fax    
Email  mmbean995@gmail.com  
 
Source of Monetary or Material Support  
JUSTICE K S HEGDE CHARITABLE HOSPITAL Deralakatte Mangalore Karnataka  
 
Primary Sponsor  
Name  MERLIT JAMES 
Address  NGSMIPS NITTE deemed to be university deralakatte mangalore 
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 
merlit james  JUSTICE K S HEGDE CHARITABLE HOSPITAL  DEPARTMENT OF GENERAL MEDICINE
Dakshina Kannada
KARNATAKA 
9744919471

mmbean995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  patients on diabetic treatment 
 
ExclusionCriteria 
Details  Type I Diabetes Mellitus.
Seriously ill patients, who were under ventilation support and in altered mental status.
Patients not giving consent.
Pregnant women.

 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
occurrence of metabolic syndrome among patients with type II DM  8 months 
 
Secondary Outcome  
Outcome  TimePoints 
gender related difference in risk factors among patients with type II DM  8 months 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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)   01/10/2019 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Diabetes Mellitus (DM) is a metabolic disease defined by hyperglycaemia due to defects in insulin secretion, insulin action, or both. The predominance of diabetes has increased worldwide in both genders equally . There is a dramatic increase in the ubiquity of diabetes owing to modernization and urbanization that has brought about a substantial burden on the health care services. Metabolic syndrome (Met S) is defined as a cluster of cardiovascular risk factors which include raised fasting plasma glucose, central obesity, and hypertension, raised triglycerides, and reduced HDL cholesterol . Also known as syndrome X or insulin resistance syndrome, it has been recognized since 1980s. The guidelines for the diagnosis of metabolic syndrome have been given by different organizations such as World Health Organization (WHO), International Diabetic Federation (IDF), and National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) imparted a new working definition of the metabolic syndrome and thus, it is easily applicable and provides strong clinical evidence. The MetS is influenced by several factors, some of which can accelerate the disease’s progression to various complications that aggravate the morbidity.

DM is associated with a three to five fold increased risk for the development of Metabolic Syndrome (Met S) which has now reached high proportions in many countries. MetS is known to be caused by insulin resistance or insulin resistance-linked obesity, a condition whereby the body’s cells are incapable of taking up glucose from the blood. Insulin resistance-linked obesity is caused by poor dieting and lack of regular exercise. Other genetic or lifestyle risk factors equally lead to the metabolic Met S. This leads to the development of macro and micro vascular complications in patients with Diabetes Mellitus. There is little information on MetS causes and predictor factors, due to few published data on the prevalence of Met S and its association with type II diabetes mellitus. There are difference in the prevalence of metabolic syndrome in different ethnic population due to difference in lifestyle, distribution of different risk factors, knowledge and awareness about metabolic diseases. The primary objective of the study is to identify the occurrence of Metabolic Syndrome (Met S) among type II DM patients. Secondary objective is to assess the gender related difference in risk factors associated with metabolic syndrome. The proposed study will help to identify the occurrence of metabolic syndrome among DM population and will help to understand the association between each components of metabolic syndrome with gender. Identification of MetS in patients with DM will be useful in predicting other complications and it will help to devise more targeted interventions.

 

 
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