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NCT Number: NCT05936242

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federico II University Hospital

Naples, 80131, Italy

Location status: Recruiting

Location contact

Alessandra Corrado, ScB

SUB_INVESTIGATOR

Giovanni Annuzzi, M.D.

CONTACT

[email protected]

+39 3391693201

Giuseppe Scida, RD

SUB_INVESTIGATOR

Jumana Abuqwider, RD

SUB_INVESTIGATOR

Lutgarda Bozzetto, M.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 Diabetes

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Postprandial glucose response

    Time frame: 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).

    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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: IN-DEEP

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Jul 7, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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