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Impact of Meal Composition and Alcohol Consumption on Postprandial Glycemic Control in Subjects With Type 1 Diabetes

6. marts 2020 opdateret af: Jorge Bondia

Evaluación Del Impacto de la composición Nutricional de la Ingesta y Del Consumo de Alcohol en el Control glucémico Postprandial en Pacientes Con Diabetes Tipo 1

Postprandial glucose control is a challenging issue in everyday diabetes care. Indeed, excessive postprandial glucose excursions are the major contributors to plasma glucose (PG) variability in subjects with type 1 diabetes (T1DM). In addition, the poor reproducibility of postprandial glucose response is burdensome for patients and healthcare professionals.

To date, the majority of prandial insulin dosing algorithms for subjects with T1DM considers only the carbohydrate (CHO) content of the meal. However, there is evidence (although with a certain degree of heterogeneity) that meal composition significantly affects postprandial glucose control, contributing to glycemic variability. Moreover, despite the high prevalence of alcohol consumption among patients with T1DM (about 30%, similar to that of the general population), data regarding its effect on the postprandial period are very limited.

This project will evaluate the effect of meal composition and alcohol consumption on postprandial glucose control in subjects with T1DM under intensive insulin treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Randomized, prospective, single-centre (Hospital Francesc de Borja, Gandia, Spain), single-blind (analysis), three -way, crossover study on type 1 diabetic subjects (n=12) under intensive insulin treatment.

Aim:

To assess the effect of mixed meal composition on postprandial glycemic control, in subjects with type 1 diabetes:

  1. Combined effect of proteins and fats
  2. Effect of alcohol consumption

Methods:

Each subject will undergo three mixed meal test studies (on three different days), with identical CHO content: On one occasion a low fat-low protein meal will be given, and on another a high fat-high protein one, both consumed with a non-alcoholic drink; on a third occasion the same high fat-high protein meal will be consumed, but this time accompanied by an equal volume of an alcoholic drink.

Patients will arrive at the research unit at 8:00 am and their blood glucose will be stabilized around 90 mg/dl before each mixed meal test. After the mixed meal, blood will be drawn every 5-30 min during a 6 hour post-prandial period to assess plasma glucose, hormones and metabolites concentration.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Valencia
      • Gandia, Valencia, Spanien, 46072
        • Hospital Francesc de Borja

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Patients with type 1 diabetes mellitus for more than one year, aged between 18 and 60 years; on intensive insulin therapy by means of CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for at least 6 months before screening; glycosylated haemoglobin of 6-8.5%; without severe chronic micro- and macroangiopathic diabetic complications and with a body mass index (BMI) between 18 and 30 kg/m2.

Exclusion Criteria:

  • Pregnancy and lactation
  • Hypoglycemia unawareness
  • Fatal or progressive disease
  • Drugs or alcohol abuse
  • HIV, active hepatitis B, active hepatitis C
  • Hepatic disease (aminotransferases AST or ALT >2 times above normal)
  • Clinically relevant microangiopathic disease, or other diseases that may interfere with participation in the study or data analysis
  • Pre-planned surgery
  • Blood donation in the previous 3 months for men and 6 months for women
  • Mental conditions that may interfere with the subject's comprehension of the aims and possible consequences of the study
  • Non-compliant subjects
  • Use of experimental medications or devices during the previous 30 days

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Low Protein-Low Fat study
Subjects will receive a mixed meal with carbohydrates (70g) plus a low content of proteins and fats
Andet: Mixed meal with different macronutrient composition
A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
Eksperimentel: High Protein-High Fat study
Subjects will receive a mixed meal with the same carbohydrates content of arm 1 (70g), but a greater amount of fats and proteins
Andet: Mixed meal with different macronutrient composition
A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
Eksperimentel: High Protein-High Fat & alcohol study
Subjects will receive the same mixed meal of the High Protein-High Fat study plus 0,7g of alcohol per Kg of weight
Andet: Mixed meal with different macronutrient composition
A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma Glucose
Tidsramme: 6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test).
Post-prandial plasma glucose time series
6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
AUC-PG
Tidsramme: AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period.
Area Under the Curve (AUC) of Plasma Glucose in the 0-6h, 0-3h and 3-6h post-prandial periods
AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time in range
Tidsramme: 6 hours (time in range during the 6 hour post-prandial period)
Time in acceptable glucose range (70-180 mg/dl)
6 hours (time in range during the 6 hour post-prandial period)
C Max
Tidsramme: 6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period)
Maximum of plasma glucose concentration
6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period)
T max
Tidsramme: 6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period)
Time of Maximum plasma glucose concentration
6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period)
Hormones and metabolites
Tidsramme: 6 hours (plasma hormones and metabolites will be measured every 30 minutes during the 6-hour post-prandial period)
Plasma concentration of free fatty acids, beta-OH-butyrate, lactate, alanine, counterregulatory hormones
6 hours (plasma hormones and metabolites will be measured every 30 minutes during the 6-hour post-prandial period)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jorge Bondia

Samarbejdspartnere

Ministerio de Economía y Competitividad, Spain
Hospital Francesc de Borja, Gandia, Spain

Efterforskere

  • Ledende efterforsker: Paolo Rossetti, PhD, Hospital Francesc de Borja, Gandia
  • Studieleder: Jorge Bondia Company, PhD, Universitat Politécnica de Valéncia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. oktober 2018

Primær færdiggørelse (Faktiske)

23. januar 2020

Studieafslutning (Faktiske)

31. januar 2020

Datoer for studieregistrering

Først indsendt

20. oktober 2017

Først indsendt, der opfyldte QC-kriterier

20. oktober 2017

Først opslået (Faktiske)

25. oktober 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DPI2016-78831-C2-1-R_alcohol

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