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NCT Number: NCT02821585

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

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).

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional counseling

Behavioral

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 outcomes

  1. Change in Waist Circumference

    Time frame: 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 outcomes

  1. Mediterranean Diet Score

    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).

    The questionnaire allows the calculation of a score reflecting the adherence to the mediterranean diet.

  2. Body Mass Index (BMI)

    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.

    Weight (kg) / (height (m) x height (m))

  3. Percentage of body fat

    Time frame: 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

  4. Insulin Sensitivity

    Time frame: 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.

  5. Systolic and diastolic Blood pressure

    Time frame: 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

  6. Lipid profile

    Time frame: 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.

  7. Glycemic variability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Acronym: MEDIT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 1, 2016
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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