Metabolic Syndrome, Type 1 Diabetes
Conditions
Brief 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. 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).
Interventions
BEHAVIORALNutritional Counseling
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.
Sponsors
Institut de Recherches Cliniques de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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: 1. Waist circumference \>102cm ♂ or \>88cm ♀ 2. Triglycerides \>1.7mmol/L or medication 3. Cholesterol-HDL \<1.0mmol/L ♂ or \<1.3mmol/L ♀ or medication 4. Blood pressure ≥130/85 mmHg or medication 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | 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. | Weight (kg) / (height (m) x height (m)) |
| Percentage of body fat | The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months) | The outcome will be measured using a DEXA-scan |
| Insulin Sensitivity | The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months) | 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. |
| Mediterranean Diet Score | 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). | The questionnaire allows the calculation of a score reflecting the adherence to the mediterranean diet. |
| Lipid profile | The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months) | A blood test will measure level of total cholesterol, triglycerides and LDL cholesterol. |
| Glycemic variability | The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months) | Glycated hemoglobin will be measured with a blood sample. Hypoglycemia frequency will be measured with a 4-day glycemia journal. |
| Systolic and diastolic Blood pressure | The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months) | Average of 3 measures (systolic, diastolic and pulse) after a 5 minutes resting period |
Countries
Canada
Outcome results
None listed