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Continuous Glucose Monitoring to Measure Effect of Glycemic Index 7

Completato
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La sperimentazione clinica NCT01145547 è stata uno studio interventistico per Diabete mellito di tipo 1, attualmente completato. Avviato il 1 aprile 2009, prevedeva di arruolare 7 partecipanti. Sotto la guida di Legacy Health System, si è concluso il 1 ottobre 2009. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 23 ottobre 2015.
Sommario breve
Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.

Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring.

Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, bo...

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Descrizione dettagliata
A total of 14 diet studies (each with two meals) were completed in three men and four women. All subjects completed two diet studies in which two meals were served 195 minutes apart. On one study day, two high GI (> 75) meals were given, and on the other study day, two low GI (< 30) meals were given. The low GI and high GI meals were matched for amount of carbohydrates, protein, and fat based on a weight-maintainin...Mostra di più
Titolo ufficiale

The Effect of Glycemic Index on Post-prandial Glycemia (Breakfast vs. Lunch) in Patients With Type 1 Diabetes: Quantification With Continuous Glucose Monitoring

Patologie
Diabete mellito di tipo 1
Altri ID dello studio
  • kw01
Numero NCT
NCT01145547
Data di inizio (effettiva)
2009-04
Ultimo aggiornamento pubblicato
2015-10-23
Data di completamento (stimata)
2009-10
Arruolamento (previsto)
7
Tipo di studio
Interventistico
FASE
N.D.
Stato
Completato
Parole chiave
glycemic index
Diabetes Mellitus
continuous glucose monitoring
Scopo principale
Terapia di supporto
Allocazione
Randomizzato
Modello di intervento
Studio incrociato
Mascheramento
Singolo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Comparatore attivolow glycemic index effect on post-prandial peak
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
Dexcom Seven® Plus Continuous Glucose Monitoring sensor
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Comparatore attivohigh glycemic index effect on post-prandial peak
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
Dexcom Seven® Plus Continuous Glucose Monitoring sensor
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Mean Area Under the Curve for Rise in Breakfast Post-prandial.
Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.
Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast
Criteri di eleggibilità

Età idonea
Bambino, Adulto, Adulto anziano
Sessi idonei
Tutti
Accetta volontari sani
Sì
  • clinical diagnosis of type 1 diabetes mellitus
  • patients on insulin pump therapy

Any patient who was

  • pregnancy
  • cardiovascular, cerebrovascular, kidney, or liver disease
  • uncontrolled chronic medical conditions
  • oral or parenteral corticosteroid use
  • immunosuppressant use
  • visual or physical impairments that impede the use of a continuous glucose monitoring device
  • insulin or glucagon allergy
  • hypoglycemia unawareness
  • requirement of greater than 200 units of insulin per day
  • gastroparesis
  • any prior gastric surgery
  • an allergy to any food items served.
Legacy Health System logoLegacy Health System
Juvenile Diabetes Research Foundation logoJuvenile Diabetes Research Foundation
Parte responsabile dello studio
W. Kenneth Ward, Investigatore principale, Senior Scientist, Legacy Health System
Nessun dato di contatto
1 Centri dello studio in 1 paesi

Oregon

Legacy Health System--Holladay Park Campus, Portland, Oregon, 97232, United States