| CTRI Number |
CTRI/2021/01/030629 [Registered on: 20/01/2021] Trial Registered Prospectively |
| Last Modified On: |
19/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of risk factors, and individual components of Metabolic syndrome in diabetic patients of different age groups and genders attending Medicine OPD of AIIMS, Mangalagiri. |
|
Scientific Title of Study
|
Influence of age and gender on Clinical profile of Metabolic syndrome in diabetic patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Upparakadiyala Rakesh |
| Designation |
Assistant professor |
| Affiliation |
All India institute of medical sciences,Mangalagiri |
| Address |
Room No 217, Department of general medicine, OPD building,AIIMS, Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9492944966 |
| Fax |
|
| Email |
ukrakesh@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Upparakadiyala Rakesh |
| Designation |
Assistant professor |
| Affiliation |
All India institute of medical sciences,Mangalagiri |
| Address |
Room No 217, Department of general medicine, OPD building,AIIMS, Mangalagiri
ANDHRA PRADESH
522503
India |
| Phone |
9492944966 |
| Fax |
|
| Email |
ukrakesh@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Upparakadiyala Rakesh |
| Designation |
Assistant professor |
| Affiliation |
All India institute of medical sciences,Mangalagiri |
| Address |
Room No 217, Department of general medicine, OPD building,AIIMS, Mangalagiri
ANDHRA PRADESH
522503
India |
| Phone |
9492944966 |
| Fax |
|
| Email |
ukrakesh@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
| All India institute of medical sciences, Mangalagiri, |
|
|
Primary Sponsor
|
| Name |
Upparakadiyala Rakesh |
| Address |
Assistant professor,Room No 217, Department of general medicine, OPD building,AIIMS, Mangalagiri |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 |
| Upparakadiyala Rakesh |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Mangalagiri. |
Room No. 216
OUT PATIENT DEPARTMENT, General Medicine
AIIMS, Mangalagiri
Guntur
ANDHRA PRADESH |
9492944966
ukrakesh@aiimsmangalagiri.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ,AIIMS MANGALAGIRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult diabetic patients aged >19 years attending General Medicine Outpatient department |
|
| ExclusionCriteria |
| Details |
1)Patients on steroids
2)pregnant women |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will assess the prevalence, risk factors, and components of Metabolic syndrome among different age groups and genders of diabetic patients |
BASE LINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will assess the components of Metabolic syndrome among different age groups and genders of diabetic patients |
BASE LINE |
|
|
Target Sample Size
|
Total Sample Size="382"
Sample Size from India="382"
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)
|
26/01/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a comparative cross-sectional study which will assess the prevalence, risk factors, and components of Metabolic syndrome among different age groups and genders of diabetic patients. This study will be conducted at All India institute of medical sciences, Mangalagiri. Ageing is an important factor that affects the metabolic abnormalities leading to an increase in the prevalence of Metabolic syndrome. Metabolic syndrome is more prevalent in female diabetic patients with risk factors & common core components different from male patients. FINDINGS AND APPLICATION Knowledge of the risk factors for metabolic syndrome may be utilized in interventions which favourably alter its prevalence. Knowing the common components of metabolic syndrome and their regular screening will guide in management, minimizing the risk of development of complications. Age-specific and Gender-specific management strategies for metabolic syndrome can be adopted. |