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

29 januari 2019 uppdaterad av: Institut de Recherches Cliniques de Montreal
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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

29

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kanada
    • Quebec
      • Montréal, Quebec, Kanada, H2W1R7
        • Institut de recherches cliniques de Montréal

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Beteende: 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-jämförare: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Waist Circumference
Tidsram: 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).
Change from baseline and 6 months measure of waist circumference

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mediterranean Diet Score
Tidsram: 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.
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)
Tidsram: 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))
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
Tidsram: 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
The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Insulin Sensitivity
Tidsram: 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.
The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months)
Systolic and diastolic Blood pressure
Tidsram: 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
The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Lipid profile
Tidsram: 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.
The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Glycemic variability
Tidsram: 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.
The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Institut de Recherches Cliniques de Montreal

Utredare

  • Studierektor: Remi Rabasa-Lhoret, IRCM

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2016

Primärt slutförande (Faktisk)

1 april 2018

Avslutad studie (Faktisk)

1 april 2018

Studieregistreringsdatum

Först inskickad

20 juni 2016

Först inskickad som uppfyllde QC-kriterierna

29 juni 2016

Första postat (Uppskatta)

1 juli 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 januari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 januari 2019

Senast verifierad

1 september 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MEDIT-1

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