Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome

Study Overview
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Brief Summary
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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).

Official Title
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Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome

Conditions
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Type 1 Diabetes, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Nutritional Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mediterranean Diet<br>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. | Behavioral: Nutritional Counseling<br>* 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.<br>|
| Placebo Comparator: Low Fat Diet<br>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. | Behavioral: Nutritional Counseling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change from baseline and 6 months measure of waist circumference | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mediterranean Diet Score | The questionnaire allows the calculation of a score reflecting the adherence to the mediterranean diet. | 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)) | 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 | 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. | 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 | 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. | 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. | The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months) |