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CTRI Number  CTRI/2022/05/042420 [Registered on: 09/05/2022] Trial Registered Prospectively
Last Modified On: 08/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association of Chronotype, Sleep Quality, Dietary Intake, Eating Pattern and Perceived Stress with Glycaemic Control in Individuals with Type 2 Diabetes. 
Scientific Title of Study   Association of Chronotype, Sleep Quality, Dietary Intake, Eating Pattern and Perceived Stress with Glycaemic Control in Individuals with Type 2 Diabetes Aged 18-45 Years: A Cross-sectional Observational Study in Mumbai, India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ammara Mohammed Khalid 
Designation  Post-graduate Student 
Affiliation  Sir Vithaldas Thackersey College of Home Science (Autonomous), SNDT Women’s University 
Address  B-9/304, Millat Nagar, Andheri (W), Mumbai- 400053, Maharashtra, India

Mumbai (Suburban)
MAHARASHTRA
Mumbai - 400053
India 
Phone  8779745901  
Fax    
Email  amr2khan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ammara Mohammed Khalid 
Designation  Post graduate Student 
Affiliation  Sir Vithaldas Thackersey College of Home Science (Autonomous), SNDT Women’s University 
Address  B-9/304, Millat Nagar, Andheri (W), Mumbai- 400053, Maharashtra, India

Jalna
MAHARASHTRA
Mumbai - 400053
India 
Phone  8779745901  
Fax    
Email  amr2khan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jagmeet Madan 
Designation  Principal, Professor, SVT College of Home Science; National President, Indian Dietetic Association 
Affiliation  Sir Vithaldas Thackersey College of Home Science (Autonomous), SNDT Women’s University 
Address  Sir Vithaldas Thackersey College of Home Science (Autonomous), Juhu Tara Road, Santacruz (W), Mumbai- 400049, Maharashtra, India

Mumbai
MAHARASHTRA
Mumbai - 400049
India 
Phone  9869239178  
Fax    
Email  principal@svt.edu.in  
 
Source of Monetary or Material Support  
SVT College of home Science, SNDT Womens University, Mumbai 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [No primary sponsor] 
 
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 
Ammara Mohammed Khalid  Millat Hospital  Room number 9, Department of Diabetology, Karat Multiplex, 24, SV Rd, Shastri Nagar, Jogeshwari West, Mumbai, Maharashtra 400102
Mumbai
MAHARASHTRA 
8779745901

amr2khan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seva Mandal Education Society’s Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Adults with Type 2 Diabetes aged 18 – 45 years will be included.
A case of type 2 diabetes will be considered confirmed if at least one of the following was reported (Eastwood et al., 2016):
a. Self-reported disease, medication, and type 2 diabetes diagnosis in medical history;
b. HbA1c greater than 6.5%;
c. Use of hypoglycaemic medications (e.g., Metformin)
 
 
ExclusionCriteria 
Details  Other forms of Diabetes
Pregnant and lactating mothers, or any neurological or physical impairment that required the participants to depend on others for feeding.
Nursing home residents, institutionalized patients, and patients receiving alternate routes of nutrition such as tube feeding or parenteral nutrition will also be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The relationship between chronotype and glycaemic control in patients diagnosed with type 2 diabetes will get ascertained.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
The relationship between sleep quality, dietary eating pattern, perceived stress and glycaemic control in patients with type 2 diabetes will get determined.   6 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   10/05/2022 
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="0"
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 cross sectional study aims to study the association of chronotype, sleep quality, dietary intake, eating pattern and perceived stress with glycaemic control in type 2 diabetics aged 18-45 years. The primary outcome will be the relationship between chronotype and glycaemic control in patients diagnosed with type 2 diabetes. The secondary outcome will be relationship between sleep quality, dietary eating pattern, perceived stress and glycaemic control in patients with type 2 diabetes. 
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