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Additional Insulin for High Fat/Protein in Type 1 Diabetes

9 december 2021 bijgewerkt door: Yasemin Atik Altinok, Ege University

The Effect of Fat - Protein Counting on Glycemic Variability in Children and Adolescents With Type 1 Diabetes Mellitus

Aim: Dietary carbohydrate is the predominant macronutrient affecting postprandial blood glucose excursions, dietary fat and protein can also significantly impact the postprandial glycemic profile. The aim of this study is to compare the impact of additional dose of extended insulin bolus; using Pankowsko algorithm (PA) to usual standard carbohydrate counting (CC) on postprandial glucose excursions for high fat /high energy density mixed meal for 12 hours.

Methods: In this single-center, non-blinded, randomized, crossover study a high fat, high energy density test meal containing 80 gram carbohydrate (34%), 70 gram fat (66%) and 35 g protein (14%) was given using standard carbohydrate counting (CC) on the first test day and PA was used for the second test day for the same meal. Two methods were compared on postprandial early (0-120 min), late (120-720 min) and total (0-720 min) glucose response in 20 patients with type 1 diabetes mellitus (T1DM), aged 9-18 years on continuous subcutan insulin infusion (CSII) therapy using continuous glucose monitoring system (CGMS).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Children and adolescents with T1DM between the ages of 9-18 and undergoing insulin infusion pump therapy followed in Ege University Pediatric Endocrinology Department will be randomly selected regardless of metabolic control. The selection of the cases will be made from the beginning of the study as the first 30 patients who meet the research participation criteria and agree to participate in the study. Before the research starts, the cases will be told about the application of CGMS, their responsibilities in the research, and an appointment will be given for the insertion of CGMS and this procedure will be applied to all participants. On the day of the appointment, the participant will be put on CGMS, and as long as CGMS is attached, they will be asked to measure capillary blood glucose in their diaries and record them. The subjects will be checked whether they are within the target blood glucose values for 2 days before consuming the test meal and normoglycemia will be provided. On the first day of the study, a test meal with 80 g carbohydrate (29.3%), 70.2 g fat (57.9%), 34.7 g protein (12.7%), will be consumed in the evening meal and carbohydrate counting-normal bolus insulin will be given by administration. On the second day of the study, the additional insulin for fat and protein will be given as a dual wave bolus instead of the normal bolus for the test meal. Then, CGMS will be extracted from the cases, transferred to the computer, and analysis will be made by the researcher, taking into account the capillary blood glucose measurements in the diary.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Kalkoen
      • İzmir, Kalkoen, 35100
        • Ege University Faculty of Medicine Department of Pediatrics

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

9 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Children-adolescents with Type 1 DM between the ages of 9-18 and undergoing insulin infusion pump therapy followed by Ege University Faculty of Medicine, Department of Pediatric Endocrine.
  2. Those with a body mass index between -2- + 2 SD

Exclusion Criteria:

  1. Cases that do not accept to fill in the 'Informed Consent Form'
  2. Cases with diseases accompanying T1DM (autoimmune diseases such as celiac, cystic fibrosis, etc.)
  3. Body mass index <-2 SD and> +2 SD

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: carb counting
Patients using insulin infusion pumps will be placed CGMS for 2 days before starting the study to check whether they are within the target blood glucose levels and normoglycemia will be provided. The content of the first day of the study; The test meal, which is 80 g carbohydrate (29.3%), 70.2 g fat (57.9%), 34.7 g protein (12.7%), will be consumed in the evening meal and normal bolus insulin will be given according to carbohydrate counting. On the second day of the study, instead of the normal bolus for the test meal, the additional insulin for fat-protein by dual wave bolus that.The data obtained will be analyzed by evaluating the CGMS data of all patients by a pediatric endocrinologist experienced in diabetes, CGMS and insulin infusion pump therapy.
Ander: Carb and fat counting
In the 7 days leading up to the study, participants were contacted to review blood glucose levels with CGMS, food and activity diary. basal rates and insulin carbohydrate ratio and sensitivity factor were changed according to the CGMS values and normoglycemia was achieved.In the study day same meals were served which included high fat, high energy density test meal containing 80 gram carbohydrate (34%), 70 gram fat (66%) and 35 g protein (14%).The participants had to have no glucose fluctuations 2 hours before study entry based on CGMS, no correction boluses for at least 4 hours before the test meal consumption and fasting glycemia in the range of 70-180 mg/dL on both study days.The participants received the test meal calculating insulin dose by CC on the first study day and calculating insulin dose by and fat/protein counting in the second study day. The test meal consumption was completed in 20 minutes under supervision by a caregiver and a dietician of the research team

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
AUC
Tijdsspanne: AUC was evaluated the day where only carbs were counted and the day were fat and proteins were counted
The primary outcomes were glucose area under the curve (AUC) and % of time spent in normoglycemia according to CC; PA and modified PA algorithms.
AUC was evaluated the day where only carbs were counted and the day were fat and proteins were counted

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
hypoglycemia epizode
Tijdsspanne: Hypoglycemia was evaluated the day where only carbs were counted and the day were fat and proteins were counted
The secondary outcomes were the number of hypoglycemic events over the study period based on capillary blood glucose measurements.
Hypoglycemia was evaluated the day where only carbs were counted and the day were fat and proteins were counted

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ege University

Onderzoekers

  • Studie stoel: Sukran Darcan, MD Prof, Ege university
  • Hoofdonderzoeker: Yasemin Atik Altınok, pHD, Ege University Fac Of Medicine Department of Pediatrics
  • Hoofdonderzoeker: Hafize Cetin Işıklar, Nurse, Ege University Fac Of Medicine Department of Pediatrics
  • Hoofdonderzoeker: Gunay Demir, MSci Nurse, Ege University Fac Of Medicine Department of Pediatrics
  • Hoofdonderzoeker: Samim Ozen, MD,PhD, Ege University Fac Of Medicine Department of Pediatrics

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2017

Primaire voltooiing (Werkelijk)

30 april 2018

Studie voltooiing (Werkelijk)

31 december 2019

Studieregistratiedata

Eerst ingediend

29 november 2021

Eerst ingediend dat voldeed aan de QC-criteria

29 november 2021

Eerst geplaatst (Werkelijk)

9 december 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 december 2021

Laatste update ingediend die voldeed aan QC-criteria

9 december 2021

Laatst geverifieerd

1 december 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 16-12.1/44

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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