Type 2 Diabetes MellitusNCT03380988
Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease
A study testing Acute test meal with fiber-enriched buckwheat pasta and Acute test meal with corn pasta in people with Type 2 Diabetes Mellitus and Celiac Disease, run by Federico II University at 1 site in Italy.
Trial summary
The intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Celiac Disease
- What is being tested?
- Acute test meal with fiber-enriched buckwheat pasta and Acute test meal with corn pasta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to Feb 2017
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 20-50 years
- Documented history of celiac disease and type 1 diabetes.
Who cannot join
- Pregnancy/breast feeding
- Serious microvascular and macrovascular diabetes complications
- Any other chronic or acute disease apart from diabetes seriously affecting health status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fiber-enriched Buckwheat Pasta Reduces Daily Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease: an Acute Randomized Controlled Trial
The intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the experimental period, participants underwent CGM, wearing their sensors 7 days/week.
- Conditions
- Type 2 Diabetes Mellitus, Celiac Disease
- Being tested
- Acute test meal with fiber-enriched buckwheat pasta, Acute test meal with corn pasta
- Medical subject headings
- Diabetes Mellitus, Type 2, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute test meal with fiber-enriched buckwheat pastaOther
Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
Acute test meal with corn pastaOther
Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
| Study group | Role | What they receive |
|---|---|---|
| Fiber-enriched buckwheat pasta | Experimental | Acute test meal Receives: Other: Acute test meal with fiber-enriched buckwheat pasta |
| Corn pasta | Active comparator | Acute test meal Receives: Other: Acute test meal with corn pasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose response
Incremental area under the curve
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study startNov 2015
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
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
- NCT03380988
- Sponsor's protocol ID
- 175/15
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiber-enriched Buckwheat Pasta Reduces Daily Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease: an Acute Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03380988
- Acronym / sponsor ID
- 175/15
- Conditions
- Type 2 Diabetes Mellitus, Celiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 21 Dec 2017 (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 intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the experimental period, participants underwent CGM, wearing their sensors 7 days/week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber-enriched buckwheat pasta | Experimental | Other: Acute test meal with fiber-enriched buckwheat pastaAcute test meal |
| Corn pasta | Active comparator | Other: Acute test meal with corn pastaAcute test meal |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 20-50 years
- Documented history of celiac disease and type 1 diabetes.
Key exclusion criteria (3 listed)
- Pregnancy/breast feeding
- Serious microvascular and macrovascular diabetes complications
- Any other chronic or acute disease apart from diabetes seriously affecting health status
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 |
|---|---|---|
| Acute test meal with fiber-enriched buckwheat pastaPasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil) | Other | Fiber-enriched buckwheat pasta |
| Acute test meal with corn pastaPasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil) | Other | Corn pasta |
Primary outcome
Postprandial glucose response
Time frame: 6 hours
Incremental area under the curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute test meal with fiber-enriched buckwheat pasta and Acute test meal with corn pasta in people with Type 2 Diabetes Mellitus and Celiac Disease, 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 2 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: finished, as of the sponsor's last update on 21 Dec 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose response (time frame: 6 hours). 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 21 Dec 2017.