Type 1 DiabetesFACILENCT02330939
Fats And Carbohydrates Quality on Postprandial glycemIc Response in Type 1 Diabetes
A study testing Low fat- Low glycemic index meal, MUFA- Low glycemic index meal and SAFA- Low glycemic index meal in people with Type 1 Diabetes, run by Federico II University at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether dietary fats may affect postprandial glycemic response differently according to their quality, and these effects may differ whether they are assumed in the context of meals with high or low glycemic index in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Low fat- Low glycemic index meal, MUFA- Low glycemic index meal and SAFA- Low glycemic index meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Dec 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Type 1 diabetes treated by insulin pump
Who cannot join
- Pregnancy
- Celiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Fats And Carbohydrates Quality on Postprandial glycemIc Response in People With Type 1 diabEtes on Insulin Pump (FACILE Study)
The purpose of this study is to determine whether dietary fats may affect postprandial glycemic response differently according to their quality, and these effects may differ whether they are assumed in the context of meals with high or low glycemic index in patients with type 1 diabetes. This interaction between quality of fat and glycemic index of carbohydrates may have clinical implication for the calculation of prandial insulin dose in these patients.
- Conditions
- Type 1 Diabetes
- Being tested
- Low fat- Low glycemic index meal, MUFA- Low glycemic index meal, SAFA- Low glycemic index meal, Low fat- High glycemic index meal, MUFA- High glycemic index meal
- Keywords
- Postprandial glycemia, Momounsaturated fatty acids, Saturated fatty acids, Glycemic index, Glycemic load, Sensor augmented pump system
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat- Low glycemic index mealOther
MUFA- Low glycemic index mealOther
SAFA- Low glycemic index mealOther
Low fat- High glycemic index mealOther
MUFA- High glycemic index mealOther
SAFA- High glycemic index mealOther
| Study group | Role | What they receive |
|---|---|---|
| Low fat- Low glycemic index | Active comparator | Participants consumed a meal with low glycemic index and poor in fat Receives: Other: Low fat- Low glycemic index meal |
| MUFA- Low glycemic index | Experimental | Participants consumed a meal with low glycemic index and rich in MUFA Receives: Other: MUFA- Low glycemic index meal |
| SAFA- Low glycemic index | Experimental | Participants consumed a meal with low glycemic index and rich in SAFA Receives: Other: SAFA- Low glycemic index meal |
| Low fat- High glycemic index | Active comparator | Participants consumed a meal with high glycemic index and low in fat Receives: Other: Low fat- High glycemic index meal |
| MUFA- High glycemic index | Experimental | Participants consumed a meal with high glycemic index and rich in MUFA Receives: Other: MUFA- High glycemic index meal |
| SAFA- High glycemic index | Experimental | Participants consumed a meal with high glycemic index and rich in SAFA Receives: Other: SAFA- High glycemic index meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial incremental glucose AUC
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 posted5 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT02330939
- Sponsor's protocol ID
- 980/14
- Acronym
- FACILE
- Status last verified
- Jan 2015
- First submitted
- 1 Jan 2015
- Last updated
- 5 Jan 2015
- Results posted
- No
Publications
Bozzetto L, Alderisio A, Clemente G, Giorgini M, Barone F, Griffo E, Costabile G, Vetrani C, Cipriano P, Giacco A, Riccardi G, Rivellese AA, Annuzzi G. Gastrointestinal effects of extra-virgin olive oil associated with lower postprandial glycemia in type 1 diabetes. Clin Nutr. 2019 Dec;38(6):2645-2651. doi: 10.1016/j.clnu.2018.11.015. Epub 2018 Dec 4.
PubMed 30567626Bozzetto L, Alderisio A, Giorgini M, Barone F, Giacco A, Riccardi G, Rivellese AA, Annuzzi G. Extra-Virgin Olive Oil Reduces Glycemic Response to a High-Glycemic Index Meal in Patients With Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2016 Apr;39(4):518-24. doi: 10.2337/dc15-2189. Epub 2016 Feb 9.
PubMed 26861923
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fats And Carbohydrates Quality on Postprandial glycemIc Response in People With Type 1 diabEtes on Insulin Pump (FACILE Study)
- ClinicalTrials.gov ID
- NCT02330939
- Acronym / sponsor ID
- FACILE / 980/14
- Conditions
- Type 1 Diabetes
- Keywords
- Postprandial glycemia, Momounsaturated fatty acids, Saturated fatty acids, Glycemic index, Glycemic load, Sensor augmented pump system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- First posted
- 5 Jan 2015 (estimated)
- 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 purpose of this study is to determine whether dietary fats may affect postprandial glycemic response differently according to their quality, and these effects may differ whether they are assumed in the context of meals with high or low glycemic index in patients with type 1 diabetes. This interaction between quality of fat and glycemic index of carbohydrates may have clinical implication for the calculation of prandial insulin dose in these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low fat- Low glycemic index | Active comparator | Other: Low fat- Low glycemic index mealParticipants consumed a meal with low glycemic index and poor in fat |
| MUFA- Low glycemic index | Experimental | Other: MUFA- Low glycemic index mealParticipants consumed a meal with low glycemic index and rich in MUFA |
| SAFA- Low glycemic index | Experimental | Other: SAFA- Low glycemic index mealParticipants consumed a meal with low glycemic index and rich in SAFA |
| Low fat- High glycemic index | Active comparator | Other: Low fat- High glycemic index mealParticipants consumed a meal with high glycemic index and low in fat |
| MUFA- High glycemic index | Experimental | Other: MUFA- High glycemic index mealParticipants consumed a meal with high glycemic index and rich in MUFA |
| SAFA- High glycemic index | Experimental | Other: SAFA- High glycemic index mealParticipants consumed a meal with high glycemic index and rich in SAFA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Type 1 diabetes treated by insulin pump
Key exclusion criteria (2 listed)
- Pregnancy
- Celiac disease
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 |
|---|---|---|
| Low fat- Low glycemic index meal | Other | Low fat- Low glycemic index |
| MUFA- Low glycemic index meal | Other | MUFA- Low glycemic index |
| SAFA- Low glycemic index meal | Other | SAFA- Low glycemic index |
| Low fat- High glycemic index meal | Other | Low fat- High glycemic index |
| MUFA- High glycemic index meal | Other | MUFA- High glycemic index |
| SAFA- High glycemic index meal | Other | SAFA- High glycemic index |
Primary outcome
postprandial incremental glucose AUC
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Derived from this study: PubMed 30567626Bozzetto L, Alderisio A, Clemente G, Giorgini M, Barone F, Griffo E, Costabile G, Vetrani C, Cipriano P, Giacco A, Riccardi G, Rivellese AA, Annuzzi G. Gastrointestinal effects of extra-virgin olive oil associated with lower postprandial glycemia in type 1 diabetes. Clin Nutr. 2019 Dec;38(6):2645-2651. doi: 10.1016/j.clnu.2018.11.015. Epub 2018 Dec 4.
- Derived from this study: PubMed 26861923Bozzetto L, Alderisio A, Giorgini M, Barone F, Giacco A, Riccardi G, Rivellese AA, Annuzzi G. Extra-Virgin Olive Oil Reduces Glycemic Response to a High-Glycemic Index Meal in Patients With Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2016 Apr;39(4):518-24. doi: 10.2337/dc15-2189. Epub 2016 Feb 9.
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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 Low fat- Low glycemic index meal, MUFA- Low glycemic index meal and SAFA- Low glycemic index meal in people with 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 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 5 Jan 2015. 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?
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 incremental glucose AUC (time frame: 6 hours). 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 NCT02330939, which also lists 2 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 5 Jan 2015.