DiabetesNCT05795972
Inulin Supplementation in Patients With Type 1 Diabetes
A study testing inulin and standard therapy in people with Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of this study is to compare the glycemic and metabolic control of type 1 diabetic patients in replacement therapy with insulin, comparing those treated with a supplementation of prebiotics (inulin) and those treated with a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- inulin and standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T1D, diagnosed before 35 years of age will be enrolled
Who cannot join
- advanced complications of T1D (established renal failure, severe retinopathy and diabetic neuropathy)
- BMI> 30 kg / m2.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Veronica Ojetti, 3396600996, veronica.ojetti@gmail.com
About this study
Official title: Efficacy Evaluation of Inulin Supplementation on Metabolic Control and Akkermansia Muciniphila Levels in Patients With Type 1 Diabetes: a Pilot Study
The aim of this study is to compare the glycemic and metabolic control of type 1 diabetic patients in replacement therapy with insulin, comparing those treated with a supplementation of prebiotics (inulin) and those treated with a placebo.
Therefore, the primary objective of the study is represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (HbA1c, lipid profile, C-RP).
- Conditions
- Diabetes
- Being tested
- inulin, standard therapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inulinDietary supplement
patients treated with standard therapy with a supplementation of Inulin 6g twice a day for 3 months.
standard therapyOther
control group (patients treated also with standard therapy)
| Study group | Role | What they receive |
|---|---|---|
| inulin supplementation | Experimental | Not described Receives: Dietary Supplement: inulin |
| standard therapy | Active comparator | Not described Receives: Other: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control
represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (HbA1c, lipid profile, C-RP).
Measured: 3 months
Secondary outcomes (1)
akkermania levels
evaluate the presence of Akkermansia in the gut microbiota at enrollment, and to compare its quantitative modification from the beginning to the end of the therapy, comparing inulin vs a control group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Jun 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OJETTI VERONICA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795972
- Sponsor's protocol ID
- 3099
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Inulin Supplementation on Metabolic Control and Akkermansia Muciniphila Levels in Patients With Type 1 Diabetes: a Pilot Study
- ClinicalTrials.gov ID
- NCT05795972
- Acronym / sponsor ID
- 3099
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 3 Apr 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 aim of this study is to compare the glycemic and metabolic control of type 1 diabetic patients in replacement therapy with insulin, comparing those treated with a supplementation of prebiotics (inulin) and those treated with a placebo.
Therefore, the primary objective of the study is represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (HbA1c, lipid profile, C-RP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inulin supplementation | Experimental | Dietary Supplement: inulin |
| standard therapy | Active comparator | Other: standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with T1D, diagnosed before 35 years of age will be enrolled
Key exclusion criteria (2 listed)
- advanced complications of T1D (established renal failure, severe retinopathy and diabetic neuropathy)
- BMI> 30 kg / m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inulinpatients treated with standard therapy with a supplementation of Inulin 6g twice a day for 3 months. | Dietary supplement | inulin supplementation |
| standard therapycontrol group (patients treated also with standard therapy) | Other | standard therapy |
Primary outcome
glycemic control
Time frame: 3 months
represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (HbA1c, lipid profile, C-RP).
1 secondary outcome
akkermania levels
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inulin and standard therapy in people with Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 2 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: status not confirmed, as of the sponsor's last update on 4 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact veronica ojetti, prof (3396600996, veronica.ojetti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic control (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2023.