| CTRI Number |
CTRI/2022/05/042699 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Body Composition, Nutritional Status and Sleep Patterns of Type 2 Diabetes Adults. |
|
Scientific Title of Study
|
Assessment of Body Composition, Nutritional Status and Sleep Patterns of Type 2 Diabetic Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Habiba Shaikh |
| Designation |
Student |
| Affiliation |
|
| Address |
301 304 Apsara CHS, Naya Nagar Pooja nagar road, Mira Road (East) Thane-401107
Mumbai
MAHARASHTRA
400019
India |
| Phone |
-7039533358 |
| Fax |
|
| Email |
habbishaikh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratnaraje Thar |
| Designation |
Co ordinator of Self Finance Course |
| Affiliation |
College of Home Science Nirmala Niketan |
| Address |
College of Home Science, Nirmala Niketan, 49, New Marine Lines, Mumbai, Maharashtra 400020
Mumbai
MAHARASHTRA
400020
India |
| Phone |
9820136367 |
| Fax |
|
| Email |
ratna.thar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ratnaraje Thar |
| Designation |
Research Director and Coordinator |
| Affiliation |
College of Home Science Nirmala Niketan |
| Address |
MEHERINA building, B block,1st floor, Flat no12 A,C-51Nepeansea road, Near Simla House Godrej Baug Mumbai 26
College of Home Science Nirmala Niketan,49, New Marine Lines Mumbai - 400020 Maharashtra, India
Mumbai
MAHARASHTRA
400006
India |
| Phone |
9820136367 |
| Fax |
|
| Email |
ratna.thar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swastik Hospital and Research Centre, 22, Deepak Kumar Marg, Swastik Park, Chembur, Mumbai, Maharashtra 400071 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Ratnaraje Thar |
Swastik Hospital and Research Centre |
22, Deepak Kumar Marg, Swastik Park, Chembur, Mumbai, Maharashtra 400071
Mumbai
MAHARASHTRA |
9820136367
ratna.thar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SEVA MANDAL EDUCATION SOCIETYS INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetic adults who are on oral drugs and insulin therapy without any complications |
|
| ExclusionCriteria |
| Details |
Type 1 diabetic adults
Type 2 diabetic adults with other complications
Healthy population |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body Composition, Sleep Pattern and Dietary Recall |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
27/05/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Type II diabetes (TTDM) is a chronic disease where the body is unable to utilize the insulin produced by the pancreas. People suffering from type II diabetes is said to be insulin resistant. Alterations in genes, aging, excess weight or body fat around the waist or hip, chronic stress, gestational diabetes, eating disorders, inactive lifestyle are certain factors contributing to type II diabetes. Change in body composition also depends/varies according to gender, ethnicity, calorie intake, and physical activity.The insulin sensitivity and glucose tolerance is impaired due to lack of sleep and also increases an adverse health effects on diabetic individuals. |