PrediabetesTEFANCT02605148
TEFA Family Prevention: Glutenfree Diet to Preserve Beta-cell Function
A study testing Gluten free diet, Omega 3 fatty acid and Vitamin D in people with Prediabetes and Type 1 Diabetes, run by Lund University at 1 site in Sweden.
Trial summary
To evaluate the effect of Gluten Free Diet (GFD) on beta-cell function and glucose metabolism in subjects with one or several islet autoantibodies without and with dysglycemia at baseline. Additionally, all subjects will be given treatment with Vitamin D, omega fatty acids and probiotics. Read more about this study
- Who is it for?
- Ages 2 to 49 years
- Conditions the study is for
- Prediabetes, Type 1 Diabetes
- What is being tested?
- Gluten free diet, Omega 3 fatty acid and Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2015to Dec 2022
- 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 2 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects from two (2) to 49,99 years of age.
- At least one type 1 diabetes-associated autoantibody (to glutamic acid (GADA), insulin (IAA), insulinoma-associated protein 2 (IA-2A) or zinktransporter 8 (ZnT8R/W/QA) in subjects with impaired glucose metabolism OR at least two type 1 diabetes-associated autoantibodies, regardless of normal or impaired glucose metabolism.
- Written informed consent from research subject. If a child, also from the child's parents or legal acceptable representative(s) according to local regulations.
Who cannot join
- Ongoing treatment with immunosuppressant therapy (topical or inhaled steroids are accepted).
- Diabetes.
- Treatment with any oral or injected anti-diabetic medications.
- Significantly abnormal hematology results at screening.
- Participation in other clinical trials with a new chemical entity within the previous 3 months.
- History of hypercalcemia.
Show all 9Show fewer
- Presence of associated serious disease or condition.
- Diabetes-protective HLA-DQ6-allele.
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Lund University, Department of Clinical Sciences Malmö
Malmö, 20502
About this study
Official title: TEFA TEDDY Family Prevention - Gluten Free Diet to Preserve Beta-cell Function in Subjects With Islet Autoimmunity.
To evaluate the effect of Gluten Free Diet (GFD) on beta-cell function and glucose metabolism in subjects with one or several islet autoantibodies without and with dysglycemia at baseline. Additionally, all subjects will be given treatment with Vitamin D, omega fatty acids and probiotics.
Subjects will be randomized to GFD or normal diet during 18 months. Beta cell function will be evaluated at baseline, and during follow-up by glucose tolerance tests.
Read the detailed description
The design is a randomized controlled study to determine the safety and the effect of gluten free diet during 18 months on beta-cell function and glucose metabolism. Lead-in and nonstop supplement cocktail including vitamin D, omega fatty acids and probiotics will be used to equalize differences to reduce known confounders. All study subjects will meet with a dietician to obtain a 3-day diet record and to receive instructions on a healthy normal diet or GFD.
Subjects (n=60) at 2-49.99 years of age positive for one or several islet autoantibodies will be recruited. Subjects with one islet autoantibody have done one or several oral glucose tolerance test (OGTT) prior to the baseline visit. One islet autoantibody positive subjects are only eligible if they have dysglycemia. All subjects will be randomized based on baseline intravenous glucose tolerance test (IvGTT) and OGTT into subjects without and with dysglycemia at baseline.
Beta-cell function and glucose metabolism (alternating IvGTT and OGTT) will be assessed at baseline and after 6, 12, 18 months of treatment and after 6 months of wash out on a normal healthy diet.
Adverse events and safety Adverse event will be obtained at visits and during the study, which will be monitored.
It is expected that subjects with one or several islet autoantibodies will show a loss compared to baseline of beta-cell function and glucose control. GFD is expected to reduce the loss in subjects on a healthy diet.
- Conditions
- Prediabetes, Type 1 Diabetes
- Being tested
- Gluten free diet, Omega 3 fatty acid, Vitamin D, Probiotics
- Keywords
- Islet autoimmunity, gluten free diet, prediabetes, prevention, type 1 diabetes, glucose tolerance test
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten free dietDietary supplement
Gluten free diet during 18 months.
Omega 3 fatty acidDietary supplement
Omega 3 fatty acid
Vitamin DDietary supplement
Vitamin D 800 U/day
ProbioticsDietary supplement
Probiotics
| Study group | Role | What they receive |
|---|---|---|
| Gluten free diet | Experimental | Gluten free diet during 18 months. The subjects will be referred to a nutritionist every 6 months. Vitamin D 800 U Daily, Omega 3 fatty acids and probiotics as nutritional supplements. Receives: Dietary Supplement: Gluten free diet; Dietary Supplement: Omega 3 fatty acid; Dietary Supplement: Vitamin D; Dietary Supplement: Probiotics |
| Normal diet | Active comparator | Normal diet. Vitamin D 800 U Daily, Omega 3 fatty acids and probiotics as nutritional supplements. Receives: Dietary Supplement: Omega 3 fatty acid; Dietary Supplement: Vitamin D; Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in first phase insulin response (FPIR) from IvGTT
Change in First phase insulin response from IvGTT during follow-up
Measured: 24 months
Change in area under the curve (AUC) C-peptide
Change in AUC C-peptide from OGTT during follow-up
Measured: 24 months
Change in glucose metabolism
Change from normal to impaired glucose metabolism during follow-up
Measured: 24 months
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
To evaluate safety of GFD compared to recommended normal diet in the placebo group in subjects supplemented with lead in and nonstop treatment with a cocktail including vitamin D, omega fatty acids and probiotics.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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 PrediabetesStudies of the same condition, open and under way.
- More trials run by Lund 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Maria Månsson Martinez, Lund University
- Investigators
- Maria Månsson Martinez, Nutricionist, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605148
- Sponsor's protocol ID
- TEFA/2015
- Acronym
- TEFA
- Status last verified
- Oct 2021
- First submitted
- 11 Nov 2015
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Martinez MM, Spiliopoulos L, Salami F, Agardh D, Toppari J, Lernmark A, Kero J, Veijola R, Tossavainen P, Palmu S, Lundgren M, Borg H, Katsarou A, Larsson HE, Knip M, Maziarz M, Torn C; and the TEDDY-Family (TEFA) Study Group. Heterogeneity of beta-cell function in subjects with multiple islet autoantibodies in the TEDDY family prevention study - TEFA. Clin Diabetes Endocrinol. 2022 Jan 5;7(1):23. doi: 10.1186/s40842-021-00135-6.
PubMed 34983671Martinez MM, Salami F, Larsson HE, Toppari J, Lernmark A, Kero J, Veijola R, Koskenniemi JJ, Tossavainen P, Lundgren M, Borg H, Katsarou A, Maziarz M, Torn C; TEDDY Family (TEFA) Study Group. Beta cell function in participants with single or multiple islet autoantibodies at baseline in the TEDDY Family Prevention Study: TEFA. Endocrinol Diabetes Metab. 2020 Nov 5;4(2):e00198. doi: 10.1002/edm2.198. eCollection 2021 Apr.
PubMed 33855205
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEFA TEDDY Family Prevention - Gluten Free Diet to Preserve Beta-cell Function in Subjects With Islet Autoimmunity.
- ClinicalTrials.gov ID
- NCT02605148
- Acronym / sponsor ID
- TEFA / TEFA/2015
- Conditions
- Prediabetes, Type 1 Diabetes
- Keywords
- Islet autoimmunity, gluten free diet, prediabetes, prevention, type 1 diabetes, glucose tolerance test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Dec 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Nov 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.
To evaluate the effect of Gluten Free Diet (GFD) on beta-cell function and glucose metabolism in subjects with one or several islet autoantibodies without and with dysglycemia at baseline. Additionally, all subjects will be given treatment with Vitamin D, omega fatty acids and probiotics.
Subjects will be randomized to GFD or normal diet during 18 months. Beta cell function will be evaluated at baseline, and during follow-up by glucose tolerance tests.
Detailed description
The design is a randomized controlled study to determine the safety and the effect of gluten free diet during 18 months on beta-cell function and glucose metabolism. Lead-in and nonstop supplement cocktail including vitamin D, omega fatty acids and probiotics will be used to equalize differences to reduce known confounders. All study subjects will meet with a dietician to obtain a 3-day diet record and to receive instructions on a healthy normal diet or GFD.
Subjects (n=60) at 2-49.99 years of age positive for one or several islet autoantibodies will be recruited. Subjects with one islet autoantibody have done one or several oral glucose tolerance test (OGTT) prior to the baseline visit. One islet autoantibody positive subjects are only eligible if they have dysglycemia. All subjects will be randomized based on baseline intravenous glucose tolerance test (IvGTT) and OGTT into subjects without and with dysglycemia at baseline.
Beta-cell function and glucose metabolism (alternating IvGTT and OGTT) will be assessed at baseline and after 6, 12, 18 months of treatment and after 6 months of wash out on a normal healthy diet.
Adverse events and safety Adverse event will be obtained at visits and during the study, which will be monitored.
It is expected that subjects with one or several islet autoantibodies will show a loss compared to baseline of beta-cell function and glucose control. GFD is expected to reduce the loss in subjects on a healthy diet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gluten free diet | Experimental | Dietary Supplement: Gluten free diet, Dietary Supplement: Omega 3 fatty acid, Dietary Supplement: Vitamin D, Dietary Supplement: ProbioticsGluten free diet during 18 months. The subjects will be referred to a nutritionist every 6 months. Vitamin D 800 U Daily, Omega 3 fatty acids and probiotics as nutritional supplements. |
| Normal diet | Active comparator | Dietary Supplement: Omega 3 fatty acid, Dietary Supplement: Vitamin D, Dietary Supplement: ProbioticsNormal diet. Vitamin D 800 U Daily, Omega 3 fatty acids and probiotics as nutritional supplements. |
Who may qualify
- Ages
- 2 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Subjects from two (2) to 49,99 years of age.
- At least one type 1 diabetes-associated autoantibody (to glutamic acid (GADA), insulin (IAA), insulinoma-associated protein 2 (IA-2A) or zinktransporter 8 (ZnT8R/W/QA) in subjects with impaired glucose metabolism OR at least two type 1 diabetes-associated autoantibodies, regardless of normal or impaired glucose metabolism.
- Written informed consent from research subject. If a child, also from the child's parents or legal acceptable representative(s) according to local regulations.
Key exclusion criteria (9 listed)
- Ongoing treatment with immunosuppressant therapy (topical or inhaled steroids are accepted).
- Diabetes.
- Treatment with any oral or injected anti-diabetic medications.
- Significantly abnormal hematology results at screening.
- Participation in other clinical trials with a new chemical entity within the previous 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten free dietGluten free diet during 18 months. | Dietary supplement | Gluten free diet |
| Omega 3 fatty acidOmega 3 fatty acid | Dietary supplement | Gluten free diet, Normal diet |
| Vitamin DVitamin D 800 U/day | Dietary supplement | Gluten free diet, Normal diet |
| ProbioticsProbiotics | Dietary supplement | Gluten free diet, Normal diet |
Primary outcome
Change in first phase insulin response (FPIR) from IvGTT
Time frame: 24 months
Change in First phase insulin response from IvGTT during follow-up
Change in area under the curve (AUC) C-peptide
Time frame: 24 months
Change in AUC C-peptide from OGTT during follow-up
Change in glucose metabolism
Time frame: 24 months
Change from normal to impaired glucose metabolism during follow-up
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Derived from this study: PubMed 34983671Martinez MM, Spiliopoulos L, Salami F, Agardh D, Toppari J, Lernmark A, Kero J, Veijola R, Tossavainen P, Palmu S, Lundgren M, Borg H, Katsarou A, Larsson HE, Knip M, Maziarz M, Torn C; and the TEDDY-Family (TEFA) Study Group. Heterogeneity of beta-cell function in subjects with multiple islet autoantibodies in the TEDDY family prevention study - TEFA. Clin Diabetes Endocrinol. 2022 Jan 5;7(1):23. doi: 10.1186/s40842-021-00135-6.
- Derived from this study: PubMed 33855205Martinez MM, Salami F, Larsson HE, Toppari J, Lernmark A, Kero J, Veijola R, Koskenniemi JJ, Tossavainen P, Lundgren M, Borg H, Katsarou A, Maziarz M, Torn C; TEDDY Family (TEFA) Study Group. Beta cell function in participants with single or multiple islet autoantibodies at baseline in the TEDDY Family Prevention Study: TEFA. Endocrinol Diabetes Metab. 2020 Nov 5;4(2):e00198. doi: 10.1002/edm2.198. eCollection 2021 Apr.
- 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.
Maria Månsson Martinez, Nutricionist principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten free diet, Omega 3 fatty acid and Vitamin D in people with Prediabetes and Type 1 Diabetes, run by Lund University at 1 site in Sweden.
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 3 inclusion and 9 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 26 Oct 2021. 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 Sweden. 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?
Change in first phase insulin response (FPIR) from IvGTT (time frame: 24 months). The study lists 3 primary outcomes in all. 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 NCT02605148, 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 26 Oct 2021.