| CTRI Number |
CTRI/2024/12/077913 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Various Cutaneous Manifestations in Obese and Overweight Children |
|
Scientific Title of Study
|
A Study of various cutaneous manifestations in obese and overweight children. |
| 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 Krishna parmar |
| Designation |
1st year PG resident |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
OPD 35,Ground floor,GCS Medical College Hospital and Research
Centre Opp DRM Office Near Chamunda Bridge Naroda Road
Ahmedabad Ahmadabad GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
OPD 35,Ground floor,GCS Medical College Hospital and Research
Centre Opp DRM Office Near Chamunda Bridge Naroda Road
Ahmedabad Ahmadabad GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
Ahmadabad
GUJARAT
380025
India |
| Phone |
9925203795 |
| Fax |
|
| Email |
drkrishna123456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan H Patel |
| Designation |
Professor and HOD |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
OPD 35,Ground floor,GCS Medical College Hospital and Research
Centre Opp DRM Office Near Chamunda Bridge Naroda Road
Ahmedabad Ahmadabad GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
OPD 35,Ground floor,GCS Medical College Hospital and Research
Centre Opp DRM Office Near Chamunda Bridge Naroda Road
Ahmedabad Ahmadabad GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
Ahmadabad
GUJARAT
380025
India |
| Phone |
9925011309 |
| Fax |
|
| Email |
nayan.patel@gcsmc.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayan H Patel |
| Designation |
Professor and HOD |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
OPD 35,Ground floor,GCS Medical College Hospital and Research
Centre Opp DRM Office Near Chamunda Bridge Naroda Road
Ahmedabad Ahmadabad GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
OPD 35,Ground floor,GCS Medical College Hospital and Research
Centre Opp DRM Office Near Chamunda Bridge Naroda Road
Ahmedabad Ahmadabad GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
Ahmadabad
GUJARAT
380025
India |
| Phone |
9925203795 |
| Fax |
|
| Email |
nayan.patel@gcsmc.org |
|
|
Source of Monetary or Material Support
|
| GCS Medical College, Hospital, and Research Centre |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 krishna parmar |
GCS Medical College Hospital and Research Centre |
Department of
dermatology GCS
Medical College
Hospital & Research
Centre Opp. DRM
Office Near Chamunda
Bridge Naroda Road
Ahmedabad
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
9925203795
drkrishna123456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee GCS medical college,hospital and reasearch centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1 obese and overweight children under 14 years having cutaneous manifestations
2 obese and overwight childern not having any genetic disorder |
|
| ExclusionCriteria |
| Details |
Age more 14 years.
â— at the time of examination patient has similar cutaneous manifestations in normal weight children
children having syndromic childhood obesity like praderwilli syndrome , bardet-beidl etc syndromes
obesity due to genetic disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the prevalence of
various cutaneous manifestation associated with obesity and overweight children |
It is a cross-sectional single-visit study on day baseline and on 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out pathology & physiology associated with cutaneous manifestation of obesity |
It is a cross-sectional single-visit study on baseline & 1ST WEEK TO 2ND WEEK |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
20/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
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
|
Thesis explore the
cutaneous manifestations in obese and overweight children. It delves into the
various skin conditions prevalent in this demographic, such as acanthosis
nigricans, stretch marks, and fungal infections. Additionally, it investigates
the underlying physiological mechanisms contributing to these manifestations,
including insulin resistance and hormonal imbalances. The study aims to raise
awareness about the dermatological implications of childhood obesity and
suggests strategies for prevention and treatment |