Evaluation of Main Determinants of Postprandial Glucose Response in Type 1 Diabetes
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorFederico II University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Type 1 Diabetes
Disqualifiers
Pregnancy and/or breastfeeding
Other chronic or acute diseases
Use of antibiotics in the past 3 months
Trial 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).
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Related to 7-days food recordSponsors and contacts
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Source ClinicalTrials.gov