Clinical trial NCT02821585: Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome
Official title: Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Metabolic Syndrome
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in Waist Circumference
timeFrame: Change from baseline and 6 months measure of waist circumference
Secondary outcomes:
measure: Mediterranean Diet Score
timeFrame: 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).
measure: Body Mass Index (BMI)
timeFrame: 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.
measure: Percentage of body fat
timeFrame: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
measure: Insulin Sensitivity
timeFrame: The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months)
measure: Systolic and diastolic Blood pressure
timeFrame: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
measure: Lipid profile
timeFrame: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
measure: Glycemic variability
timeFrame: The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: IRCM
name: Remi Rabasa-Lhoret
role: STUDY_DIRECTOR
References:
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.