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

NCT05936242 | Recruiting

• 1 other identifier: Prot. 338/20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of individuals with type 1 diabetes using continuous glucose monitoring (CGM) and regularly attending the Diabetes Outpatient Clinic of Federico II University Teaching Hospital (Naples, Italy).

You may qualify if:

• Type 1 Diabetes

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University Hospital

Naples, 80131, Italy

RECRUITING

Related Publications (2)

• Abuqwider J, Pasolli E, Scida G, Corrado A, Vitale M, De Filippis F, Ercolini D, Annuzzi G, Rivellese AA, Bozzetto L. Gut microbiome profiles and associated functional pathways are linked to Mediterranean diet adherence and blood glucose control in adults with type 1 diabetes mellitus. Nutr Metab Cardiovasc Dis. 2025 Dec 2:104487. doi: 10.1016/j.numecd.2025.104487. Online ahead of print.

  PMID: 41484024 DERIVED

• Abuqwider J, Salamone D, Scida G, Corrado A, Costabile G, Luongo D, Annuzzi G, Rivellese A, Bozzetto L. Sex-specific associations of serum short-chain fatty acids with glycaemic control: an Italian cross-sectional study in adults with type 1 diabetes. BMJ Open. 2025 Mar 24;15(3):e096994. doi: 10.1136/bmjopen-2024-096994.

  PMID: 40132856 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, buffy coat, feces, serum, and plasma

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Feeding Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior, Animal; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medical Doctor

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 7, 2023
• Study Start: May 18, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2024-10

Locations

IT (1)