Type 1 DiabetesNCT02131896
The Effects of Mediterranean Diet on Remission, Lipid Profile, Weight and Body Composition in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
A study testing Interventional arm-Mediterranean diet in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Nutritional therapy has a major role in diabetes care, achieving and maintaining metabolic control: normal glucose homeostasis, normal lipid profile, normal blood pressure and desirable weight. Controlled nutritional diet, as introduced by the professional committees aims at achieving better general health condition. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Interventional arm-Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2014to Jun 2016
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parents/guardian are willing and able to sign an informed consent form
- Age 5-18 years
- Diagnosis with type 1 diabetes for up to 2 months prior to screening
- Peak C peptide > o.2 pmol/mL
Who cannot join
- The patient has any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator might interfere with patient's compliance or ability to complete the study
- Any concomitant disease that might impact body composition, physical activity level and/or eating habits
- Active celiac disease, hashimoto thyroiditis or uncontrolled Graves' disease
- Down syndrome, Turner, inflammatory bowel disease
- Patients treated with antipsychotic drugs, steroids, or other drugs that might affect body weight and appetite.
- Patient who suffers from eating disorders
- Patients participating in other device or drug studies
Trial locations and contacts
1 site in 1 country.
About this study
Nutritional therapy has a major role in diabetes care, achieving and maintaining metabolic control: normal glucose homeostasis, normal lipid profile, normal blood pressure and desirable weight. Controlled nutritional diet, as introduced by the professional committees aims at achieving better general health condition.
There is a growing body of evidence showing that Mediterranean diet has a major role in prevention of diabetes sequelae in type 2 diabetes patients. Hitherto, the effects of Mediterranean diet on patients with type 1 diabetes has not been studied, with the exception of one Italian study.
Read more
Six months after education to consume Mediterranean diet in a cohort of 96 children with type 1 diabetes the authors observed decreased fat and cholesterol consumption, increased dietary fiber consumption, lower LDL cholesterol levels and better HDL to LDL cholesterol ratio.
The proposed study is aimed to assess the impact of Mediterranean nutrition compared to the accepted nutritional guidelines, in newly diagnosed type 1 children and adolescents on lipid profile, metabolic control, C peptide, daily insulin dose, Inflammatory parameters, endothelial function and anthropometric parameters 12 months following diagnosis.
The study designed as a two parallel arms, randomized, single center, intervention study.
Patients enrolled to the study will be randomly assigned, to one of the following groups in a 1:1 ratio. Interventional Arm: Patients assigned to the interventional arm will receive nutritional instructions of Mediterranean diet and Control Group: Patients assigned to the interventional arm will receive regular nutritional instructions in accordance with the accepted nutritional guidelines
- Conditions
- Type 1 Diabetes
- Being tested
- Interventional arm-Mediterranean diet, Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines
- Keywords
- Type 1 Diabetes, Newly diagnosed, Lipid profile, Mediterranean diet
- 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.
Interventional arm-Mediterranean dietOther
Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelinesOther
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet | Experimental | Mediterranean Diet Receives: Other: Interventional arm-Mediterranean diet |
| Regular nutritional instructions | Active comparator | Regular nutritional instructions Receives: Other: Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid profile
fasting blood lipid profile
Measured: At the end of the study-after 12 months
Secondary outcomes (10)
Metabolic control
Metabolic control expressed as HbA1c level
Measured: At the end of the study-after 12 months
mean and SD of blood glucose
Metabolic control expressed as mean and SD of downloaded blood glucose values from patient's personal glucometer
Measured: At the end of the study-after 12 months
Peak stimulated C peptide
Peak stimulated C peptide > o.2 pmol/mL
Measured: At the end of the study- after 12 months
Daily insulin dose
Daily insulin dose adjusted for body weight
Measured: At the end of the study- after 12 months
Percent of subjects who require a daily insulin dose < o,5 IU/kg
Measured: At the end of the study- after 12 months
Frequency and severity of hypoglycemic episodes
Measured: At the end of the study- after 12 months
Anthropometric parameters
Anthropometric parameters: Body weight ,BMI SDS, body composition and weight change from diagnosis to 12 months after diagnosis
Measured: At the end of the study- after 12 months
weight change from at least 1 year before diagnosis to 12 months after diagnosis
Measured: At the end of the study-after 12 months
Inflammatory parameters
Inflammatory parameters: TNF, CRP, IL-6, fibrinogen
Measured: At the end of the study-after 12 months
Endothelial function
Endothelial function: Doppler assessment of the tunica intima
Measured: At the end of the study-after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study start1 Dec 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liat de Vries, Dr, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131896
- Sponsor's protocol ID
- rmc7800ctil
- Status last verified
- Jan 2017
- First submitted
- 4 May 2014
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mediterranean Diet on Remission, Lipid Profile, Weight and Body Composition in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02131896
- Acronym / sponsor ID
- rmc7800ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Newly diagnosed, Lipid profile, Mediterranean diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 May 2014 (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.
Nutritional therapy has a major role in diabetes care, achieving and maintaining metabolic control: normal glucose homeostasis, normal lipid profile, normal blood pressure and desirable weight. Controlled nutritional diet, as introduced by the professional committees aims at achieving better general health condition.
There is a growing body of evidence showing that Mediterranean diet has a major role in prevention of diabetes sequelae in type 2 diabetes patients. Hitherto, the effects of Mediterranean diet on patients with type 1 diabetes has not been studied, with the exception of one Italian study.
Six months after education to consume Mediterranean diet in a cohort of 96 children with type 1 diabetes the authors observed decreased fat and cholesterol consumption, increased dietary fiber consumption, lower LDL cholesterol levels and better HDL to LDL cholesterol ratio.
The proposed study is aimed to assess the impact of Mediterranean nutrition compared to the accepted nutritional guidelines, in newly diagnosed type 1 children and adolescents on lipid profile, metabolic control, C peptide, daily insulin dose, Inflammatory parameters, endothelial function and anthropometric parameters 12 months following diagnosis.
The study designed as a two parallel arms, randomized, single center, intervention study.
Patients enrolled to the study will be randomly assigned, to one of the following groups in a 1:1 ratio. Interventional Arm: Patients assigned to the interventional arm will receive nutritional instructions of Mediterranean diet and Control Group: Patients assigned to the interventional arm will receive regular nutritional instructions in accordance with the accepted nutritional guidelines
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Experimental | Other: Interventional arm-Mediterranean dietMediterranean Diet |
| Regular nutritional instructions | Active comparator | Other: Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelinesRegular nutritional instructions |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Parents/guardian are willing and able to sign an informed consent form
- Age 5-18 years
- Diagnosis with type 1 diabetes for up to 2 months prior to screening
- Peak C peptide > o.2 pmol/mL
Key exclusion criteria (7 listed)
- The patient has any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator might interfere with patient's compliance or ability to complete the study
- Any concomitant disease that might impact body composition, physical activity level and/or eating habits
- Active celiac disease, hashimoto thyroiditis or uncontrolled Graves' disease
- Down syndrome, Turner, inflammatory bowel disease
- Patients treated with antipsychotic drugs, steroids, or other drugs that might affect body weight and appetite.
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 |
|---|---|---|
| Interventional arm-Mediterranean diet | Other | Mediterranean Diet |
| Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines | Other | Regular nutritional instructions |
Primary outcome
lipid profile
Time frame: At the end of the study-after 12 months
fasting blood lipid profile
10 secondary outcomes
Metabolic control
Time frame: At the end of the study-after 12 months
mean and SD of blood glucose
Time frame: At the end of the study-after 12 months
Peak stimulated C peptide
Time frame: At the end of the study- after 12 months
Daily insulin dose
Time frame: At the end of the study- after 12 months
Percent of subjects who require a daily insulin dose < o,5 IU/kg
Time frame: At the end of the study- after 12 months
Frequency and severity of hypoglycemic episodes
Time frame: At the end of the study- after 12 months
Anthropometric parameters
Time frame: At the end of the study- after 12 months
weight change from at least 1 year before diagnosis to 12 months after diagnosis
Time frame: At the end of the study-after 12 months
Inflammatory parameters
Time frame: At the end of the study-after 12 months
Endothelial function
Time frame: At the end of the study-after 12 months
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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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.
Liat de Vries, Dr principal investigator
Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional arm-Mediterranean diet in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Oct 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 Israel. 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 was stopped early (reason given: Recruitment difficulties). 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?
lipid profile (time frame: At the end of the study-after 12 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 20 Oct 2017.