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

Primary Purpose

Type 1 Diabetes, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nutritional Counseling
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de recherches cliniques de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mediterranean Diet

Low Fat Diet

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Mediterranean Diet Score
The questionnaire allows the calculation of a score reflecting the adherence to the mediterranean diet.
Body Mass Index (BMI)
Weight (kg) / (height (m) x height (m))
Percentage of body fat
The outcome will be measured using a DEXA-scan
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.
Systolic and diastolic Blood pressure
Average of 3 measures (systolic, diastolic and pulse) after a 5 minutes resting period
Lipid profile
A blood test will measure level of total cholesterol, triglycerides and LDL cholesterol.
Glycemic variability
Glycated hemoglobin will be measured with a blood sample. Hypoglycemia frequency will be measured with a 4-day glycemia journal.

Full Information

First Posted
June 20, 2016
Last Updated
January 29, 2019
Sponsor
Institut de Recherches Cliniques de Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT02821585
Brief Title
Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome
Acronym
MEDIT
Official Title
Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Cliniques de Montreal

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Active Comparator
Arm 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.
Arm Title
Low Fat Diet
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Counseling
Intervention 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.
Primary Outcome Measure Information:
Title
Change in Waist Circumference
Description
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
Secondary Outcome Measure Information:
Title
Mediterranean Diet Score
Description
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).
Title
Body Mass Index (BMI)
Description
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.
Title
Percentage of body fat
Description
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)
Title
Insulin Sensitivity
Description
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)
Title
Systolic and diastolic Blood pressure
Description
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)
Title
Lipid profile
Description
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)
Title
Glycemic variability
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remi Rabasa-Lhoret
Organizational Affiliation
IRCM
Official's Role
Study Director
Facility Information:
Facility Name
Institut de recherches cliniques de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W1R7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30459054
Citation
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.
Results Reference
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Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome

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