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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05936242
Acronym
IN-DEEP
Enrollment
200
Registered
2023-07-07
Start date
2021-05-18
Completion date
2028-01-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes, Gut Microbiota, Dietary Habits, Postprandial Glucose Response, Hybrid artificial pancreas, Continuous Glucose Monitoring

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). Blood samples and anthropometrics will be collected during hospital visit. Participants will be asked to: * record a seven-day food diary * complete EPIC food frequency questionnaire * complete questionnaires on sleep hygiene * collect a stool sample

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 PGR to the ingestion of the same meal may significantly differ 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). Patients will be asked to complete web-based questionnaires on sleep hygiene (Pittsburgh Sleep Quality Index, Epworth). Postprandial glucose response will be assessed by data derived from continuous glucose monitoring (CGM) used for clinical care. 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 epigenetics will be investigated.

Interventions

None listed

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Type 1 Diabetes

Exclusion criteria

* Pregnancy and/or breastfeeding * Other chronic or acute diseases * Use of antibiotics in the past 3 months

Design outcomes

Primary

MeasureTime frameDescription
Postprandial glucose responseRelated to 7-days food recordPostprandial 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026