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

29. januar 2019 oppdatert 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

29

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Atferdsmessig: 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 komparator: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Waist Circumference
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mediterranean Diet Score
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institut de Recherches Cliniques de Montreal

Etterforskere

  • Studieleder: Remi Rabasa-Lhoret, IRCM

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2016

Primær fullføring (Faktiske)

1. april 2018

Studiet fullført (Faktiske)

1. april 2018

Datoer for studieregistrering

Først innsendt

20. juni 2016

Først innsendt som oppfylte QC-kriteriene

29. juni 2016

Først lagt ut (Anslag)

1. juli 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. januar 2019

Sist bekreftet

1. september 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MEDIT-1

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