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An Exploratory Study on the Application of Continuous Glucose Monitoring System in the Measurement of Individual Glycemic Index After Eating Different Diets Phase 4 120 Ernährung

Unbekannter Status
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT04562454 untersucht Andere im Zusammenhang mit Diabetes. Diese interventionsstudie der Phase 4 hat den Status unbekannter status und startete am 1. Oktober 2020. Es ist geplant, 120 Teilnehmer aufzunehmen. Durchgeführt von Peking Union Medical College wird der Abschluss für 1. Oktober 2021 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. September 2020 aktualisiert.
Kurzbeschreibung
The glycemic index (GI) is used to evaluate the level of elevated blood sugar immediately after carbohydrate intake and is a classified indicator of the glycemic potential of carbohydrate-containing test foods relative to reference foods. At present, more and more clinical studies have proved that a low-GI diet is beneficial to health, and can improve blood glucose control, weight and blood lipid levels in patients w...Mehr anzeigen
Ausführliche Beschreibung
In this study, subjects with diabetes or impaired glucose tolerance were given continuous glucose monitoring (CGM) for 3 consecutive days, given a standard meal containing 50g carbohydrates and foods to be tested for GI. The purpose of this study was to explore the fluctuation of blood glucose, the time and range of blood glucose peak after eating different diets, and to guide the individual dietary choices of the su...Mehr anzeigen
Offizieller Titel

An Exploratory Study on the Application of Continuous Glucose Monitoring System in the Measurement of Individual Glycemic Index After Eating Different Diets

Erkrankungen
Diabetes
Weitere Studien-IDs
  • 20200920-JS-2450
NCT-Nummer
NCT04562454
Studienbeginn (tatsächlich)
2020-10-01
Zuletzt aktualisiert
2020-09-24
Studienende (vorauss.)
2021-10-01
Geplante Rekrutierung
120
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Unbekannter Status
Primäres Ziel
Andere
Zuteilungsmethode
Nicht randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellNormal group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
ExperimentellT1DM group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
ExperimentellT2DM group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
Experimentellother type of diabetes group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
fluctuation of blood glucose after eating different food
use the CGM to get the area under the curve of blood glucose of different food
baseline
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  1. the experimental group: patients with diabetes or impaired glucose tolerance diagnosed clinically according to the World Health Organization's (WHO) diagnostic criteria of diabetes in 1999; the control group: according to the participants of the experimental group, matched the people with normal glucose metabolism in sex, age and region.
  2. Age: 18-80 years old; 3) patients or family members who can understand the research plan and are willing to participate in this study and sign a written informed consent form and questionnaire

  1. severe acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmotic state, diabetic lactic acidosis) in the past 6 months;
  2. serious chronic complications of diabetes, such as peripheral vascular disease leading to amputation or chronic foot ulcers, end-stage renal disease, etc., the researchers do not think it is suitable to participate in this study.；
  3. patients with two or more episodes of severe hypoglycemia in the past year (such as disturbance of consciousness caused by hypoglycemia, coma, etc.), or severe unconscious hypoglycemia;
  4. patients with severe impairment or circulatory disturbance of cardiac function (NYHA grade III or above), liver function (ALT, AST or TBil above the upper limit of the normal value), renal function (serum creatinine above the upper limit of the normal value) or circulatory disturbance.；
  5. patients with mental illness, confusion and inability to take care of themselves;
  6. patients with gastrointestinal diseases;
  7. patients or their families cannot understand the conditions and objectives of this study
Peking Union Medical College Hospital logoPeking Union Medical College482 aktive klinische Studien zum Erkunden
Zentrale Studienkontakte
Kontakt: Weigang Zhao, MD, +86 69151876, [email protected]
Kontakt: Shuoning Song, 15117977900, [email protected]
Keine Standortdaten vorhanden