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

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

Sponsors

Lead Sponsor: Institut de Recherches Cliniques de Montreal

Source Institut de Recherches Cliniques de Montreal
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).

Overall Status Completed
Start Date January 2016
Completion Date April 2018
Primary Completion Date April 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Waist Circumference Change from baseline and 6 months measure of waist circumference
Secondary Outcome
Measure Time Frame
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).
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.
Percentage of body fat The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Insulin Sensitivity The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months)
Systolic and diastolic Blood pressure The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Lipid profile The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Glycemic variability The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Enrollment 29
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Nutritional Counseling

Description: 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.

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Remi Rabasa-Lhoret Study Director IRCM
Location
Facility: Institut de recherches cliniques de Montréal
Location Countries

Canada

Verification Date

September 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Mediterranean Diet

Type: Active Comparator

Description: 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.

Label: Low Fat Diet

Type: Placebo Comparator

Description: 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.

Acronym MEDIT
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov