Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06057246
Status:
RECRUITING
Last Update Posted:
2023-10-11
First Post:
2023-07-19
Brief Title:
Individual Determinants of Postprandial Glucose Response in Type 2 Diabetes
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Exploring Individual Determinants of postpranDIAl Glucose Response in Type 2 diaBEteS to opTimize Therapeutic Strategies With a Personalized Approach DIABEST
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIABEST
Brief Summary:
Postprandial glycemia PPG is a relevant determinant of glucose control in people with type 2 diabetes T2D Epidemiological and pathophysiological studies indicate that PPG is a better risk predictor for cardiovascular disease and all-cause mortality than fasting plasma glucose Therefore both fasting and postprandial glycemia should be targeted to achieve optimal glycemic control and thus prevent or reduce the risk of diabetes complications
Post-prandial glucose response PGR cannot be predicted based solely on the meals carbohydrate content Recent research using continuous glucose monitoring CGM systems has identified different patterns of PGR to a standard meal among both healthy people and individuals with type 1 diabetes Different contributors to the PGR have emerged including genotype hormonal and metabolic factors phenotype gut microbiota composition background diet sleep habits physical activity levels
The present project aims at exploring the PGR in a real-life setting in a cohort of people with T2D and identifying person-specific factors associated with different postprandial glucose patterns
To this purpose 144 individuals with T2D on treatment with diet alone or diet plus metformin will be characterized for their anthropometric metabolic and gut-microbiome features and will undergo a one-week observational period through CGM system while properly recording their food intake physical activity and sleep habits A mixed-nutrient standardized meal will be consumed at home in two occasions by each participant to investigate the intra-individual variability of the PGR Moreover in a subgroup of participants n60 divided according to anthropometric and metabolic features hormonal and metabolic response to the standardized meal will be evaluated at the hospital to explore the contribution of different T2D phenotypes to the PGR
A further step will be developing a prediction algorithm of PGR based on the intra- and inter-individual factors shown to influence postprandial glucose able to further optimize the management of T2D with precision therapeutic strategies
Post-prandial glucose response PGR cannot be predicted based solely on the meals carbohydrate content Recent research using continuous glucose monitoring CGM systems has identified different patterns of PGR to a standard meal among both healthy people and individuals with type 1 diabetes Different contributors to the PGR have emerged including genotype hormonal and metabolic factors phenotype gut microbiota composition background diet sleep habits physical activity levels
The present project aims at exploring the PGR in a real-life setting in a cohort of people with T2D and identifying person-specific factors associated with different postprandial glucose patterns
To this purpose 144 individuals with T2D on treatment with diet alone or diet plus metformin will be characterized for their anthropometric metabolic and gut-microbiome features and will undergo a one-week observational period through CGM system while properly recording their food intake physical activity and sleep habits A mixed-nutrient standardized meal will be consumed at home in two occasions by each participant to investigate the intra-individual variability of the PGR Moreover in a subgroup of participants n60 divided according to anthropometric and metabolic features hormonal and metabolic response to the standardized meal will be evaluated at the hospital to explore the contribution of different T2D phenotypes to the PGR
A further step will be developing a prediction algorithm of PGR based on the intra- and inter-individual factors shown to influence postprandial glucose able to further optimize the management of T2D with precision therapeutic strategies
Detailed Description:
The participants will undergo a 7-day observational period and acute postprandial tests with a standardized meal Before the study initiation all participants will undergo a screening visit for the assessment of inclusion and exclusion criteria Participants meeting the inclusion criteria will be instructed to collect a stool sample and will be scheduled for the experimental visit day 0 At day 0 each participant will arrive at the diabetes clinic in the morning after a 10-hour fasting to undergo
venous blood sampling for biochemical determinations
anthropometrics and blood pressure measurements
body composition evaluation bioimpedance analysis
basal metabolic rate evaluation indirect calorimetry
administrations of questionnaires for the evaluation of lifestyle habits
positioning of a subcutaneous sensor for continuous glucose monitoring CGM
Information regarding characteristics of bowel movements in the day of stool sampling will be collected according to the Bristol stool scale
The participants will be instructed to consume at home a mixed-nutrient meal at breakfast on the second day and on the last day of the observational period PGR will be assessed by CGM
Over the following 7 days participants will undergo CGM while keeping stable their own dietary and lifestyle habits and will be asked to record the following information by using a dedicated app
a 7-day food diary reporting all foods and drinks consumed including dressing portions by household measures cup spoons etc or weight and providing as much details as possible ie cooking methods brands names Seven-day food records will be discussed with a skilled dietitian to check potential mistakes and missing information Energy intake and dietary composition nutrients and non-nutrients and food groups consumption will be calculated using the Food Composition Database for epidemiological Studies in Italy of the European Institute of Oncology
any stressful event or drug assumption
In parallel during the 7-day observational period data on physical activity levels and sleep habits will be collected by using an accelerometer Actigraph medical device
At the 8th day a subgroup of 60 participants 20 with prevalent impairment of insulin sensitivity 20 with prevalent impairment of insulin secretion and 20 with prevalent visceral obesity - as determined by anthropometrics fasting C-peptide and plasma triglycerides will return to the hospital and consume the same standardized meal consumed at home Before and over 4 hours after the meal venous blood samples will be collected at fixed time points for biochemical evaluations
CGM data from 30 min before meal to 6 h after meal will be analyzed Postprandial blood glucose changes will be calculated with the trapezoidal method as the incremental area under the curve above the baseline value iAUC Predictors of early blood glucose response iAUC0-3h late blood glucose response iAUC3-6h total blood glucose response iAUC0-6h and as indicator of time-course of the blood glucose changes the difference between late and early response iAUC3-6h minus 0-3h will be evaluated using mixed-effect linear regression considering the patients identification number ID as a random effect To evaluate the significance of the random-effect factor ANOVA will be used to test for the difference between the model with and without the random effect
venous blood sampling for biochemical determinations
anthropometrics and blood pressure measurements
body composition evaluation bioimpedance analysis
basal metabolic rate evaluation indirect calorimetry
administrations of questionnaires for the evaluation of lifestyle habits
positioning of a subcutaneous sensor for continuous glucose monitoring CGM
Information regarding characteristics of bowel movements in the day of stool sampling will be collected according to the Bristol stool scale
The participants will be instructed to consume at home a mixed-nutrient meal at breakfast on the second day and on the last day of the observational period PGR will be assessed by CGM
Over the following 7 days participants will undergo CGM while keeping stable their own dietary and lifestyle habits and will be asked to record the following information by using a dedicated app
a 7-day food diary reporting all foods and drinks consumed including dressing portions by household measures cup spoons etc or weight and providing as much details as possible ie cooking methods brands names Seven-day food records will be discussed with a skilled dietitian to check potential mistakes and missing information Energy intake and dietary composition nutrients and non-nutrients and food groups consumption will be calculated using the Food Composition Database for epidemiological Studies in Italy of the European Institute of Oncology
any stressful event or drug assumption
In parallel during the 7-day observational period data on physical activity levels and sleep habits will be collected by using an accelerometer Actigraph medical device
At the 8th day a subgroup of 60 participants 20 with prevalent impairment of insulin sensitivity 20 with prevalent impairment of insulin secretion and 20 with prevalent visceral obesity - as determined by anthropometrics fasting C-peptide and plasma triglycerides will return to the hospital and consume the same standardized meal consumed at home Before and over 4 hours after the meal venous blood samples will be collected at fixed time points for biochemical evaluations
CGM data from 30 min before meal to 6 h after meal will be analyzed Postprandial blood glucose changes will be calculated with the trapezoidal method as the incremental area under the curve above the baseline value iAUC Predictors of early blood glucose response iAUC0-3h late blood glucose response iAUC3-6h total blood glucose response iAUC0-6h and as indicator of time-course of the blood glucose changes the difference between late and early response iAUC3-6h minus 0-3h will be evaluated using mixed-effect linear regression considering the patients identification number ID as a random effect To evaluate the significance of the random-effect factor ANOVA will be used to test for the difference between the model with and without the random effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None