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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
Intervention / Comparator Agent
|
|
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. |