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CTRI Number  CTRI/2022/06/043404 [Registered on: 21/06/2022] Trial Registered Prospectively
Last Modified On: 10/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to evaluate the Association of Meal Frequency and Timings, Overall Diet Quality and Nutrient Intake on Glycemic Variability measured using a Continuous Glucose Monitoring System among Indian Adults with Diabetes 
Scientific Title of Study   Association of Meal Frequency and Timings, Overall Diet Quality and Nutrient Intake on Glycemic Variability measured using a Continuous Glucose Monitoring System among Indian Adults with Diabetes: A Pilot Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Araina Trehon 
Designation  Post Graduate Student 
Affiliation  Sir Vithaldas Thackersey College of Home Science (Autonomous), SNDT Womens University 
Address  Sir Vithaldas Thackersey College of Home Science (Autonomous), Shreemati Nathibai Damodar Thackersey (SNDT) Womens University, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400049
India 
Phone  9769744491  
Fax    
Email  atrehon@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jagmeet Madan 
Designation  Principal, Professor, Sir Vithaldas Thackersey College of Home Science, National President of IDA 
Affiliation  Sir Vithaldas Thackersey College of Home Science (Autonomous), SNDT Womens University 
Address  Sir Vithaldas Thackersey College of Home Science (Autonomous), Shreemati Nathibai Damodar Thackersey (SNDT) Womens University, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400049
India 
Phone  9869239178  
Fax    
Email  dr.jagmeetmadan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Panchali Moitra  
Designation  Academic Dean and Controller of Examinations (Self Financed Programs); Assistant Professor 
Affiliation  Sir Vithaldas Thackersey College of Home Science (Autonomous), SNDT Womens University 
Address  Sir Vithaldas Thackersey College of Home Science (Autonomous), Shreemati Nathibai Damodar Thackersey (SNDT) Womens University, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400049
India 
Phone  8828025152  
Fax    
Email  panchali.moitra@svt.edu.in  
 
Source of Monetary or Material Support  
No financial support received 
 
Primary Sponsor  
Name  Ms Araina Trehon 
Address  Sir Vithaldas Thackersey College of Home Science (Autonomous), Shreemati Nathibai Damodar Thackersey Womens University, Mumbai, Maharashtra 
Type of Sponsor  Other [[Self]] 
 
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 
Araina Trehon  Sir Vithaldas Thackersey College of Home Science, S.N.D.T. Womens University   Department of Food, Nutrition and Dietetics under Department of Self Financed Programs, Santacruz West, Mumbai-400049
Mumbai
MAHARASHTRA 
9769744491

atrehon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seva Mandal Education Society’s Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1) Indian adults who are 18 years and above
2) Individuals with type 2 diabetes
3) Individuals who are currently on or would be soon put on the Continuous Glucose Monitoring System
 
 
ExclusionCriteria 
Details  1) Pregnant women or breastfeeding women
2) Severe liver dysfunction, which presented as alanine transaminase or aspartate transaminase exceeding three times the upper limit of the normal range
3) Severe kidney dysfunction, which is defined as creatinine exceeding two times the upper limit of the normal range or estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m2
4) Moderate-Severe anemia: Haemoglobin not greater than 109 g/L (10.9g/dL) in men and women (15 years and above) as per the WHO Recommendations
5) Presently suffering from any infectious diseases such as Covid-19 (SARS-CoV-2), tuberculosis, etc
6) Participation in another ongoing clinical trial
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of nutrient and energy intake as well as diet quality on Glycemic Control by assessing the Mean Glucose and Glycosylated hemoglobin A1C (HbA1C)  Mean Glucose: 3 days
Glycosylated hemoglobin A1C (HbA1C): previous 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of meal frequency and timings, physical activity, sleep quality on glycemic variability   3 days
sleep quality: past month 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   25/06/2022 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [atrehon@gmail.com].

  6. For how long will this data be available start date provided 01-01-2023 and end date provided 01-01-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is an observational study with an aim to assess the influence of meal frequency and timings, diet quality, nutrient intake, physical activity and sleep on glycemic variability and glycemic control as measures using a Continuous Glucose Monitoring System (CGMS) among Indian adults with Diabetes Mellitus. The variables that would be measured include the socio-demographic characteristics, anthropometric measures, biochemical parameters, clinical data, dietary intake, diet quality, physical activity, sleep quality and glycemic variability. This study can help towards extending the contribution in the field of diabetes aiming at blood glucose management by bringing about associations of frequency of eating and meal timings, overall diet quality, nutrient intake, and lifestyle behaviours such as physical activity and sleep on glycemic variability indices and glycemic control.  
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