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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
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|Eligible Ages||3 Years - 18 Years|
Inclusion Criteria:- Type 1 diabetes according to the ADA classification with < 1 months diabetes duration at time of screening - Age 3.00 -17.99 years at time of screening - Fasting C-peptide at time of screening ≥ 0.12 nmol/L
Exclusion Criteria:- Inability or unwillingness to comply with the provisions of this protocol - Deemed by the investigator not being able to follow instructions and/or follow the study protocol NB: new ethical approval will be applied for children between 1-3 years of age
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Annelie Carlsson, MD PhD|
|Principal Investigator Affiliation||Lund University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Diabetes Mellitus, Type 1, Remission, Celiac Disease in Children|
General project outline Our aim is to perform a intervention study whether one year gluten free diet in children with newly diagnosed TID would make it possible to influence the speed of the beta-cells destruction and if this diet decrease the risk to develop CD after the disease A power calculation shows that we would need 600 participants to detect clinically relevant effects (see power calculation). As the power calculation is based on estimated effects we plan to first perform a pilot study including 100 patients. Based on the results of the pilot study we then plan to continue to design a larger study to get more robust information. All children will also at the start study and, after 1 and 2 years receive a KID-screen form to study the quality of life of time in children with diabetes and to compare children with diabetes without CD and to them who will develop or have undiagnosed CD. Furthermore all children will also be monitored by a dietician during the study period, at onset, after 1 and 2 years according to the content (protein, fat, carbohydrate, gluten and vitamins) during the study. Population Consecutive patients with recent onset of diabetes at Swedish paediatric clinics are given information about the study and they and their parents are asked to participate in the trial. Informed consent given by patients and guardians/parents and inclusion criteria are; 1. Type 1 diabetes according to the ADA classification with < 1 months diabetes duration at time of screening 2. Age 3.00 -17.99 years at time of screening 3. Fasting C-peptide at time of screening ≥ 0.12 nmol/L Exclusion Criteria 1. Inability or unwillingness to comply with the provisions of this protocol 2. Deemed by the investigator not being able to follow instructions and/or follow the study protocol Recruitment and Screening Eligible subjects and their parent(s) / guardian(s) will have the study explained to them, and will receive a written patient information. If, after this, the subjects agree to participate, they will personally sign and date the written informed consent form. In accordance with the Declaration of Helsinki, the investigator must explain to the patient that they have the right to withdraw from the study at any time, and that this will in no way prejudice their future treatment Sample size, power calculation: We are planning the study as a continuous response from independent control and experimental subjects with 1 control per experimental subject. In a similar study the response within each subject group was normally distributed with standard deviation 0,19. If the true difference in the experimental and control means is 0,05 we will need to study 250 subjects and 250 controls to be able to reject the null hypothesis that the population means of the experimental and control group are equal with a probability (power) 0,8. The Type 1 error probability associated with this test of this null hypothesis is 0,05. Recalculation of sample size is needed on a pilot study, which we have chosen to 100 subjects, 50 in each group. This field also benefit from that smaller and shorter trials are conducted to obtain initial sense of efficacy prior to undertake a fully powered study. The risk to develop CD in the children with gluten free diet will be compared to the 8000 children in the BDD who had been followed yearly with transglutaminse autoantibodies for CD. Study Design The trial is designed as a 2-arm not randomized, open, multicentre study comparing 1 year of gluten free diet with normal diet. In the pilot study 100 patients will be recruited at 7 sites in Sweden (and if the pilot study shows expected results we will include all 43 Swedish pediatric clinics and altogether an estimated 600 patients). The patients will not be randomized into two parallel groups as it could influence the compliance to a normal diet. Instead we will recruit group A (50 patients) during the first year and group B with 50 age and sex-matched patients during the second year. Group A will eat gluten free diet for a year after the onset of diabetes and B normal diet. Both groups will follow the same procedures according to the study visits and clinical routines in our diabetes care and follow up. Eligibility: Patients who qualify for the study have to have a C-peptide over above 0.12 nmol/L and will be assigned with a number and this screening number together with the clinics, site number, will be used as patient identification. The patients will be assessed for eligibility at the screening visit (Visit 1) prior to the start of treatment with glutenfree diet and screened with a MMTT (mixed meal tolerance test) and fasting C-peptide levels. The patients will be followed for a total study period of 60 months which includes not more than 6 extra visits for the study (however these visits may be combined with regular diabetes care visits though all children with diabetes use to attend outpatient clinic at least every 3 month and more often at the onset of the disease) Visit 1; 2 month within the onset, MMT and fasting C-peptide Visit 2; If eligible, randomized to group A (the first 50), contact with a dietitian, information of GFD, within 3 month from onset Visit 3; at 6 months; fasting C-peptide, immunological analyses and contact with a dietician; questionnaire and a registry (before the visit one week registry of the diet intake) Visit 4; at 12 months; MMTT fasting C-peptide, HbA1c, immunological analyses. HbA1c, immunological analyses for research, contact with a dietician; questionnaire and a registry (before the visit one week registry of the diet intake) Visit 5; at 18 months, MMTT fasting C-peptide, HbA1c, immunological analyses. HbA1c, immunological analyses, including Ttg (transglutaminse) Visit 6; at 24 months, MMTT fasting C-peptide, HbA1c, immunological analyses. HbA1c, immunological analyses, including Ttg (transglutaminse) yearly until 60 months. Questionnaire about quality of life and gluten content. Both group A and B will have same information and visits according to the diabetes care where contacts with a dietician is mandatory, but arm A will need special information about a gluten free diet and will also have x-support according to gluten free products. Both group A and B will be followed according to CD risk during 5 years with Ttg annually as a clinical routine. Experimental strategy AIM 1
- - To investigate changes in beta-cell function the patients will undergo an MMTT (measuring C-peptide, 90 minute value and AUCmean 0-120 min) at basile baseline (Visit 1) to 12 and 18 months).
- - We will also investigate and compare the proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L after 12 and 18 months respectively as well as fasting C-peptide, change between baseline and month 6, 12 and 18 months between the groups.
- - Differences between metabolic control, Hemoglobin A1c (HbA1c), change between baseline and subsequent visits - Hemoglobin A1c (HbA1c, marker of metabolic control)) as marker for long term hyperglycemia will be analyzed at baseline and subsequent visits in both groups.
Experimental: Group A
Group A:withdrawal of gluten from the diet, Group A will have a gluten free diet for a year after the onset of diabetes
No Intervention: B normal diet
Group B will have normal not glutenfree diet, no planned intervention
Other: - withdrawal of gluten from the diet
Gluten free diet the same recommendations as for patients with diabetes and known celiac disease
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