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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
Intervention / Comparator Agent
|
|
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
- 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).
- What additional supporting information will be shared?
Response - None of the above
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [atrehon@gmail.com].
- 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.
- 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. |