Exploring factors affecting blood sugar levels after meals in type 1 diabetes
Evaluation of the INteraction Between Diet, microbiomE and Epigenetic Towards Personalized Interventions in Type 1 Diabetes (IN-DEEP Study)
This study looks at how different foods and gut bacteria affect blood sugar levels after meals in people with type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05936242 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the determinants of postprandial glucose response (PGR) in individuals with type 1 diabetes. Participants will record their dietary habits over a week, complete food frequency questionnaires, and provide stool samples to analyze gut microbiota composition. Blood samples will also be collected to evaluate various metabolic factors. Continuous glucose monitoring will be utilized to assess PGR, allowing for a comprehensive understanding of how different factors influence blood sugar control after meals.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with type 1 diabetes who regularly attend the diabetes outpatient clinic.
Not a fit: Patients who are pregnant, breastfeeding, or have other chronic or acute diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations and management strategies for individuals with type 1 diabetes.
How similar studies have performed: While studies have explored dietary impacts on glucose response, this specific investigation into gut microbiota's role in type 1 diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 Diabetes Exclusion Criteria: * Pregnancy and/or breastfeeding * Other chronic or acute diseases * Use of antibiotics in the past 3 months
Where this trial is running
Naples
- Federico II University Hospital — Naples, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.