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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
Intervention / Comparator Agent
|
|
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.
|