Exploring Individual Determinants of postpranDIAl Glucose Response in Type 2 diaBEteS to opTimize Therapeutic Strategies With a Personalized Approach (DIABEST)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 (n=60), 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: f
View:

• Men and post-menopausal women

• HbA1c ≤ 7.5%

• Body Mass Index (BMI) 20-39.9 kg/m2

• Ability to comply with the study protocol activities.

Locations
Other Locations
Italy
Department of Clinical Medicine and Surgery Federico II University
RECRUITING
Naples
Contact Information
Primary
Angela A Rivellese, Professor
rivelles@unina.it
00390817463665
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2025-05
Participants
Target number of participants: 144
Treatments
Experimental: Men and post-menopausal women with type 2 diabetes on treatment with diet or diet plus metformin
Each participant will undergo anthropometrics and blood pressure measurements, bioimpedance analysis, indirect calorimetry, administrations of questionnaires for the evaluation of lifestyle habits, 7 days continuous glucose monitoring in parallel with diet, physical activity and sleep monitoring, and standard mixed-nutrient meals at home; a subgroup of 60 participants will undergo venous blood sampling for biochemical determinations before and after a standard mixed-nutrient meal.
Sponsors
Leads: Federico II University

This content was sourced from clinicaltrials.gov