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Continuous Glucose Monitoring to Measure Effect of Glycemic Index 7

Abgeschlossen
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Die klinische Studie NCT01145547 untersuchte Typ-1-Diabetes mellitus als interventionsstudie und hat den Status abgeschlossen. Die Studie begann am 1. April 2009 mit 7 Teilnehmern. Sie wurde durchgeführt von Legacy Health System und am 1. Oktober 2009 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 23. Oktober 2015 aktualisiert.
Kurzbeschreibung
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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Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
Typ-1-Diabetes mellitus
Weitere Studien-IDs
  • kw01
NCT-Nummer
NCT01145547
Studienbeginn (tatsächlich)
2009-04
Zuletzt aktualisiert
2015-10-23
Studienende (vorauss.)
2009-10
Geplante Rekrutierung
7
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Abgeschlossen
Stichwörter
glycemic index
Diabetes Mellitus
continuous glucose monitoring
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Crossover-Design
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Aktives Vergleichspräparatlow 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.
Aktives Vergleichspräparathigh 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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • 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
Verantwortliche Partei
W. Kenneth Ward, Hauptprüfer, Senior Scientist, Legacy Health System
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern

Oregon

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