IN-DEEP: Evaluation of Main Determinants of Postprandial Glucose Response in Type 1 Diabetes

Sponsor

Federico II University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05936242

Collaborator

(none)

200

Enrollment

Location

42.5

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to explore inter- and intra-individual determinants of postprandial glucose response in patients with type 1 diabetes using continous glucose monitoring (CGM).

A blood glucose sample will be collected during hospital visit. Participants will be asked to:

record a seven-day food diary
complete EPIC food frequency questionnaire
collect a stool sample.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes

Detailed Description

Postprandial glucose response (PGR) is a main determinant of blood glucose control in people with type 1 diabetes (T1D) and it's still difficult to manage also in patients treated with advanced technologies. Dietary composition of meals represents one of main determinant of PGR. However, growing evidence indicates that the PGR to the ingestion of the same meal may differ significantly between individuals. This effect could be explained by non-nutritional determinants, including gut microbiota composition. On this background, the aim of the study is to investigate the relative contribution of intra- and inter-individual variability in determining PGR in individuals with type 1 diabetes.

Patients with T1D regularly attending the diabetes outpatient clinic of Federico II University Teaching Hospital, will be recruited. Participants eating habits will be collected through a 7-day food record and the European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaire. Fasting blood samples will be collected for the evaluation of serum short-chain fatty acids, zonulin, metabolomic, and epigenetics. Moreover, participants will be asked to collect at home a stool sample to determine gut microbiota composition (16s RNA sequencing). Postprandial glucose response will be assessed by data derived from continuous glucose monitoring (CGM) already used for clinical aims.

The association between the PGR, calculated as incremental AUC using the trapezoidal method, and gut microbiota composition will be assessed. Moreover, the association between PGR, dietary composition, metabolomics and epigenetic will be investigated.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Evaluation of the INteraction Between Diet, microbiomE and Epigenetic Towards Personalized Interventions in Type 1 Diabetes (IN-DEEP Study)

Actual Study Start Date :

May 18, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

Postprandial glucose response and gut microbiota composition [Related to 7-days food record]
Postprandial glucose response wil be calculated by the trapezoidal method as the area under the curve above the baseline value (iAUC) and gut microbiota composition will derived from the analysis of stool samples by shotgun metagenomics sequencing.
Postprandial glucose response and dietary composition [Related to 7-days food record]
Postprandial glucose response wil be calculated by the trapezoidal method as the area under the curve above the baseline value (iAUC) and energy intake and dietary composition will derived from the analysis of 7-days food record calculated using the MetaDieta software (Meteda s.r.l., Roma, Italy, version 4.6.1), on the basis of the Italian food composition tables of the Center of Research for Food and Nutrition (CREA) and the Food Composition Database for epidemiological Studies in Italy of the European Institute of Oncology.