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

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).

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Type 1 Diabetes
• Intervention / Treatment: Behavioral: Nutritional Counseling

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2W1R7
      • Institut de Recherches Cliniques de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mediterranean Diet; 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; 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.
Placebo Comparator: Low Fat 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.	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal
• Investigators: Study Director: Remi Rabasa-Lhoret, IRCM

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Disease; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus; Syndrome; Diabetes Mellitus, Type 1; Metabolic Syndrome
• Other Study ID Numbers: MEDIT-1