Type 1 DiabetesIN-DEEPNCT05936242
Evaluation of Main Determinants of Postprandial Glucose Response in Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 18 May 2021to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Type 1 Diabetes
Who cannot join
- Pregnancy and/or breastfeeding
- Other chronic or acute diseases
- Use of antibiotics in the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Federico II University Hospital
Naples, 80131
Giovanni Annuzzi, M.D., +39 3391693201, annuzzi@unina.it
Lutgarda Bozzetto, M.D.
About this study
Official title: Evaluation of the INteraction Between Diet, microbiomE and Epigenetic Towards Personalized Interventions in Type 1 Diabetes (IN-DEEP Study)
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
Read the 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.
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Gut Microbiota, Dietary Habits, Postprandial Glucose Response, Hybrid artificial pancreas, Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Related to 7-days food record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start18 May 2021
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936242
- Sponsor's protocol ID
- Prot. 338/20
- Acronym
- IN-DEEP
- Status last verified
- Oct 2024
- First submitted
- 30 Jun 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abuqwider J, Pasolli E, Scida G, Corrado A, Vitale M, Giosue A, Filippis F, Ercolini D, Annuzzi G, Rivellese AA, Bozzetto L. Ultra-processed food intake and its associations with atherogenic dyslipidemia, glycemic control, and gut microbiome features in adults with type 1 diabetes from Southern Italy. Diabetes Res Clin Pract. 2026 Aug;238:113373. doi: 10.1016/j.diabres.2026.113373. Epub 2026 Jun 24.
PubMed 42341885Abuqwider 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. 2026 Apr;36(4):104487. doi: 10.1016/j.numecd.2025.104487. Epub 2025 Dec 2.
PubMed 41484024D'Abbronzo G, Scida G, Quaglia C, Rivellese AA, Bozzetto L, Annuzzi G, Vitale M. Application-Based Bioelectrical Impedance Analysis Provides Accurate Body Composition Parameters in a More Cost-Efficient and Time-Efficient Way. J Nutr. 2025 Jul;155(7):2443-2448. doi: 10.1016/j.tjnut.2025.05.013. Epub 2025 May 14.
PubMed 40379027Abuqwider 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.
PubMed 40132856
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the INteraction Between Diet, microbiomE and Epigenetic Towards Personalized Interventions in Type 1 Diabetes (IN-DEEP Study)
- ClinicalTrials.gov ID
- NCT05936242
- Acronym / sponsor ID
- IN-DEEP / Prot. 338/20
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Gut Microbiota, Dietary Habits, Postprandial Glucose Response, Hybrid artificial pancreas, Continuous Glucose Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Type 1 Diabetes
Key exclusion criteria (3 listed)
- Pregnancy and/or breastfeeding
- Other chronic or acute diseases
- Use of antibiotics in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 42341885Abuqwider J, Pasolli E, Scida G, Corrado A, Vitale M, Giosue A, Filippis F, Ercolini D, Annuzzi G, Rivellese AA, Bozzetto L. Ultra-processed food intake and its associations with atherogenic dyslipidemia, glycemic control, and gut microbiome features in adults with type 1 diabetes from Southern Italy. Diabetes Res Clin Pract. 2026 Aug;238:113373. doi: 10.1016/j.diabres.2026.113373. Epub 2026 Jun 24.
- Derived from this study: PubMed 41484024Abuqwider 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. 2026 Apr;36(4):104487. doi: 10.1016/j.numecd.2025.104487. Epub 2025 Dec 2.
- Derived from this study: PubMed 40379027D'Abbronzo G, Scida G, Quaglia C, Rivellese AA, Bozzetto L, Annuzzi G, Vitale M. Application-Based Bioelectrical Impedance Analysis Provides Accurate Body Composition Parameters in a More Cost-Efficient and Time-Efficient Way. J Nutr. 2025 Jul;155(7):2443-2448. doi: 10.1016/j.tjnut.2025.05.013. Epub 2025 May 14.
- Derived from this study: PubMed 40132856Abuqwider 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose response (time frame: Related to 7-days food record). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05936242, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.