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

Not yet recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Effect of meal frequency and timings, physical activity, sleep quality on glycemic variability	3 days

Locations (1): Sir Vithaldas Thackersey College of Home Science, S.N.D.T. Womens University
🇮🇳
Mumbai, MAHARASHTRA, India
Sir Vithaldas Thackersey College of Home Science, S.N.D.T. Womens University
🇮🇳Mumbai, MAHARASHTRA, India
Araina Trehon
Principal investigator
9769744491
atrehon@gmail.com