Type 1 DiabetesMEDITNCT02821585
Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome
A study testing Nutritional Counseling in people with Type 1 Diabetes and Metabolic Syndrome, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
Recent studies have found that up to 45 % of patients with type 1 diabetes have metabolic syndrome, a cluster of conditions (abdominal obesity, hypertension, dyslipidemia, insulin resistance) that increase the cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Metabolic Syndrome
- What is being tested?
- Nutritional Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Apr 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 Diabetes for at least 12 months
- On intensive insulin therapy with multiple daily injections or on insulin pump
- Be overweight or obese (BMI≥25 kg/m2)
- Stable weight for at least 3 months
- If on medication for thyroid, hypertension or dislipidemia: stable doses in the last 3 months
- Presenting at least 3 of the 5 following criteria for metabolic syndrome:
Show all 11Show fewer
- Waist circumference >102cm ♂ or >88cm ♀
- Triglycerides >1.7mmol/L or medication
- Cholesterol-HDL <1.0mmol/L ♂ or <1.3mmol/L ♀ or medication
- Blood pressure ≥130/85 mmHg or medication
- Estimated insulin resistance (eGDR <6.29)
Who cannot join
- Mental incapacity, refusal or linguistic barrier that could affect comprehension or cooperation with the study
- Ongoing pregnancy
- Diet corresponding to the criteria of a mediterranean diet (score≥27)
- Vegetarianism
- Major diabetes complications
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W1R7
About this study
Recent studies have found that up to 45 % of patients with type 1 diabetes have metabolic syndrome, a cluster of conditions (abdominal obesity, hypertension, dyslipidemia, insulin resistance) that increase the cardiovascular risk. The investigators have observed in previous studies a strong association between the adherence to a Mediterranean diet and the prevalence of metabolic syndrome on patients with metabolic syndrome. However, no intervention has been realized on this population and the current recommendations (low fat diet) differ from the Mediterranean diet. A nutritional intervention on the principles of the Mediterranean diet could therefore play a role in the treatment of the metabolic syndrome in Type 1 diabetes patients. The main objective of this study is to examine the impact of a nutritional intervention on the waist circumference after 6 months of an intervention group (Mediterranean diet) versus a control group (low fat diet).
- Conditions
- Type 1 Diabetes, Metabolic Syndrome
- Being tested
- Nutritional Counseling
- Medical subject headings
- Diabetes Mellitus, Type 1, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional CounselingBehavioural
Carbohydrate counting will be reviewed, as well as hypoglycemia management. The 9 following visits will focus on different aspects of each diets: types of fats, meat and alternatives, grain products, milk and alternatives, fruits and vegetables, salt intake, energy density and restaurants.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet | Active comparator | Participants will receive nutritional lessons on the principles of the Mediterranean diet. This type of diet is defined with a carbohydrate intake of 45-55% of total energy intake, 15-20% of proteins, 30-35% of lipids and less than 7% for saturated fat. Nine sessions with a nutritionist are planned to cover various topics of the diet. Receives: Behavioral: Nutritional Counseling |
| Low Fat Diet | Placebo comparator | Participants will receive nutritional lessons on the principles of the low fat diet. This type of diet is defined with a carbohydrate intake greater than 45% of total energy intake, 15-20% of proteins, less than 30% of lipids and less than 7% for saturated fat. Nine sessions with a nutritionist are planned to cover various topics of the diet. Receives: Behavioral: Nutritional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Waist Circumference
The outcome will be measured every month, at admission and visits 4 (1 month) - 6 (2 months) -7 (3 months) -8 (4 months) -9 (5 months) -10 (6 months) -11 (9 months).
Measured: Change from baseline and 6 months measure of waist circumference
Secondary outcomes (7)
Mediterranean Diet Score
The questionnaire allows the calculation of a score reflecting the adherence to the mediterranean diet.
Measured: The outcome will be measured based on an internet food frequency questionnaire filled by patients at admission, visit 7 (3 months) and visit 10 (6 months).
Body Mass Index (BMI)
Weight (kg) / (height (m) x height (m))
Measured: Weight wil be measured every month: at admission and visit 4 (1 month), 6 (2 months), 7 (3 months), 8 (4 months), 9 (5 months) and 10 (6 months). The height will be measured only at admission.
Percentage of body fat
The outcome will be measured using a DEXA-scan
Measured: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Insulin Sensitivity
The outcome will be estimated based on a formula validated for type 1 diabetes subjects. The formula takes into account waist/hip ratio, glycated hemoglobin and hypertension.
Measured: The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months)
Systolic and diastolic Blood pressure
Average of 3 measures (systolic, diastolic and pulse) after a 5 minutes resting period
Measured: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Lipid profile
A blood test will measure level of total cholesterol, triglycerides and LDL cholesterol.
Measured: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Glycemic variability
Glycated hemoglobin will be measured with a blood sample. Hypoglycemia frequency will be measured with a 4-day glycemia journal.
Measured: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Remi Rabasa-Lhoret, Study director, IRCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821585
- Sponsor's protocol ID
- MEDIT-1
- Acronym
- MEDIT
- Status last verified
- Sep 2017
- First submitted
- 20 Jun 2016
- Last updated
- 31 Jan 2019
- Results posted
- No
Publications
Fortin A, Rabasa-Lhoret R, Lemieux S, Labonte ME, Gingras V. Comparison of a Mediterranean to a low-fat diet intervention in adults with type 1 diabetes and metabolic syndrome: A 6-month randomized trial. Nutr Metab Cardiovasc Dis. 2018 Dec;28(12):1275-1284. doi: 10.1016/j.numecd.2018.08.005. Epub 2018 Aug 30.
PubMed 30459054
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02821585
- Acronym / sponsor ID
- MEDIT / MEDIT-1
- Conditions
- Type 1 Diabetes, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 1 Jul 2016 (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.
Recent studies have found that up to 45 % of patients with type 1 diabetes have metabolic syndrome, a cluster of conditions (abdominal obesity, hypertension, dyslipidemia, insulin resistance) that increase the cardiovascular risk. The investigators have observed in previous studies a strong association between the adherence to a Mediterranean diet and the prevalence of metabolic syndrome on patients with metabolic syndrome. However, no intervention has been realized on this population and the current recommendations (low fat diet) differ from the Mediterranean diet. A nutritional intervention on the principles of the Mediterranean diet could therefore play a role in the treatment of the metabolic syndrome in Type 1 diabetes patients. The main objective of this study is to examine the impact of a nutritional intervention on the waist circumference after 6 months of an intervention group (Mediterranean diet) versus a control group (low fat diet).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Active comparator | Behavioral: Nutritional CounselingParticipants will receive nutritional lessons on the principles of the Mediterranean diet. This type of diet is defined with a carbohydrate intake of 45-55% of total energy intake, 15-20% of proteins, 30-35% of lipids and less than 7% for saturated fat. Nine sessions with a nutritionist are planned to cover various topics of the diet. |
| Low Fat Diet | Placebo comparator | Behavioral: Nutritional CounselingParticipants will receive nutritional lessons on the principles of the low fat diet. This type of diet is defined with a carbohydrate intake greater than 45% of total energy intake, 15-20% of proteins, less than 30% of lipids and less than 7% for saturated fat. Nine sessions with a nutritionist are planned to cover various topics of the diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Type 1 Diabetes for at least 12 months
- On intensive insulin therapy with multiple daily injections or on insulin pump
- Be overweight or obese (BMI≥25 kg/m2)
- Stable weight for at least 3 months
- If on medication for thyroid, hypertension or dislipidemia: stable doses in the last 3 months
Key exclusion criteria (5 listed)
- Mental incapacity, refusal or linguistic barrier that could affect comprehension or cooperation with the study
- Ongoing pregnancy
- Diet corresponding to the criteria of a mediterranean diet (score≥27)
- Vegetarianism
- Major diabetes complications
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 |
|---|---|---|
| Nutritional CounselingCarbohydrate counting will be reviewed, as well as hypoglycemia management. The 9 following visits will focus on different aspects of each diets: types of fats, meat and alternatives, grain products, milk and alternatives, fruits and vegetables, salt intake, energy density and restaurants. | Behavioural | Low Fat Diet, Mediterranean Diet |
Primary outcome
Change in Waist Circumference
Time frame: Change from baseline and 6 months measure of waist circumference
The outcome will be measured every month, at admission and visits 4 (1 month) - 6 (2 months) -7 (3 months) -8 (4 months) -9 (5 months) -10 (6 months) -11 (9 months).
7 secondary outcomes
Mediterranean Diet Score
Time frame: The outcome will be measured based on an internet food frequency questionnaire filled by patients at admission, visit 7 (3 months) and visit 10 (6 months).
Body Mass Index (BMI)
Time frame: Weight wil be measured every month: at admission and visit 4 (1 month), 6 (2 months), 7 (3 months), 8 (4 months), 9 (5 months) and 10 (6 months). The height will be measured only at admission.
Percentage of body fat
Time frame: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Insulin Sensitivity
Time frame: The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months)
Systolic and diastolic Blood pressure
Time frame: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Lipid profile
Time frame: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Glycemic variability
Time frame: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
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 31 Jan 2019.
- Derived from this study: PubMed 30459054Fortin A, Rabasa-Lhoret R, Lemieux S, Labonte ME, Gingras V. Comparison of a Mediterranean to a low-fat diet intervention in adults with type 1 diabetes and metabolic syndrome: A 6-month randomized trial. Nutr Metab Cardiovasc Dis. 2018 Dec;28(12):1275-1284. doi: 10.1016/j.numecd.2018.08.005. Epub 2018 Aug 30.
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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.
Remi Rabasa-Lhoret study director
IRCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Counseling in people with Type 1 Diabetes and Metabolic Syndrome, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
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 11 inclusion and 5 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 31 Jan 2019. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Change in Waist Circumference (time frame: Change from baseline and 6 months measure of waist circumference). 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 NCT02821585, which also lists 1 linked publication.
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 31 Jan 2019.