Evaluation of Main Determinants of Postprandial Glucose Response in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— IN-DEEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936242
• Other study ID #: Prot. 338/20
• Status: Recruiting
• Start date: May 18, 2021
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 may differ to the ingestion of the same meal 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 faecal 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 1 Diabetes

Exclusion Criteria:

• Pregnancy and/or breastfeeding

• Other chronic or acute diseases

• Use of antibiotics in the past 3 months

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Italy	Federico II University Hospital	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glucose response	Postprandial glucose response wil be calculated by the trapezoidal method as the area under the curve above the baseline value (iAUC).; The association between iAUC and gut microbiota composition derived from the analysis of faeces samples will be assessed. The association between iAUC and energy intake and dietary composition derived from the analysis of 7-days food record and EPIC will be assessed.	Related to 7-days food record