An interventional study of Nutritional Counseling in Type 1 Diabetes and Metabolic Syndrome, sponsored by Institut de Recherches Cliniques de Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by Institut de Recherches Cliniques de Montreal · Not applicable, Interventional, and Treatment
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).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 29 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Institut de Recherches Cliniques de Montreal is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
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Presenting at least 3 of the 5 following criteria for metabolic syndrome:
Exclusion Criteria:
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
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
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.
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).
Time frame: Change from baseline and 6 months measure of waist circumference
Mediterranean Diet Score
The questionnaire allows the calculation of a score reflecting the adherence to the mediterranean diet.
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)
Weight (kg) / (height (m) x height (m))
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
The outcome will be measured using a DEXA-scan
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Institut de Recherches Cliniques de Montreal