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Effect of Carbohydrate Distribution on Blood Glucose in Women With Gestational Diabetes Mellitus (GDM) 15

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 NCT03835208 ist eine interventionsstudie zur Untersuchung von Gestationsdiabetes und hat den Status unbekannter status. Die Studie startete am 25. Februar 2019 und soll 15 Teilnehmer aufnehmen. Durchgeführt von Universität Aarhus ist der Abschluss für 1. Mai 2020 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 30. September 2019 aktualisiert.
Kurzbeschreibung
This study aims to investigate whether high-morning carbohydrate intake (HMK) compared with low-morning carbohydrate intake (LMK) affects glycemic variability in GDM patients based on Continuous glucose monitoring (CGM).

High carbohydrate morning intake is expected to reduce hyperglycemic episodes and stabilize blood glucose compared with low morning carbohydrate intake.

Ausführliche Beschreibung
Background:

Women with GDM have an increased risk of macrosomia, cesarean section, birth defects and long term complications such as an increased risk, in both mother and child, to develop type 2 diabetes.

According to Invitro and invivo studies of type 1 and 2 diabetes, great variations in blood glucose levels caused more complications than constantly elevated glucose levels. This study, therefore, intends to use ...

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Offizieller Titel

The Effect of High-morning-carbohydrate Intake Versus Low-morning-carbohydrate Intake on Glycemic Variability Measured by Continuous Glucose Monitoring in GDM Patients - a Randomized Crossover Study

Erkrankungen
Gestationsdiabetes
Weitere Studien-IDs
  • HMKvLMK
NCT-Nummer
NCT03835208
Studienbeginn (tatsächlich)
2019-02-25
Zuletzt aktualisiert
2019-09-30
Studienende (vorauss.)
2020-05-01
Geplante Rekrutierung
15
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Unbekannter Status
Stichwörter
gestational diabetes
carbohydrate distribution
high/low carbohydrate
glycemic variability
MAGE
continuous glucose monitoring
Pregnancy in Diabetics
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Crossover-Design
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellLow-morning-carbohydrate
Low morning intake and high evening intake of carbohydrates. This means a distribution of carbohydrate as follows: 10% morning, 40% lunch, 50% dinner. The overall recommendations for macro- and micronutrient intake for GDM patients will be met.
High/low carbohydrate distribution
A total of 2x3 days, were the patient follow a detailed diet plan. For 3 days they follow a diet plan where the majority of the carbohydrates are located on either the first part of the day(HMK) or the last part of the day(LMK). 4 days of washout are placed between the two interventions. They will not receive food but will be guided by a trained dietitian and the use of a meal plan.
ExperimentellHigh-morning-carbohydrate
High morning intake and low evening intake of carbohydrates. This means a distribution of carbohydrate as follows: 50% morning, 40% lunch, 10% dinner. The overall recommendations for macro- and micronutrient intake for GDM patients will be met.
High/low carbohydrate distribution
A total of 2x3 days, were the patient follow a detailed diet plan. For 3 days they follow a diet plan where the majority of the carbohydrates are located on either the first part of the day(HMK) or the last part of the day(LMK). 4 days of washout are placed between the two interventions. They will not receive food but will be guided by a trained dietitian and the use of a meal plan.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
mean amplitude of glucose excursions (MAGE)
An index for glycemic variability assessment MAGE is the average variation in amplitude and is calculated as the mean of absolute value differences between adjacent glucose peaks and valleys, where the differences exceed 1 Standard Deviation (SD) from the mean.
6 days
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Coefficient of variation
Coefficient of variation
6 days
MBG
The average blood glucose, calculated for each two intervention periods using CGM data.
6 days
Glucagon-like-peptide 1 (GLP1)
glucagon-like-peptide 1, difference in 1 hour postprandial response
1 hour *2
Gastric inhibitory polypeptide (GIP)
Gastric inhibitory polypeptide difference in 1 hour postprandial response
1 hour*2
C-peptide
Changes in C-peptide according to carbohydrate distribution
11 days
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
  • Gestational diabetes mellitus diagnosed according to current WHO criteria for a 2-hour oral glucose tolerance test (OGTT) > 8.5 mmol/l
  • Non-insulin depending
  • Adult 18+ years
  • Gestational age weeks 30-36 at start of inclusion

  • Diagnosed with celiac disease
  • Received bariatric surgery
  • Diagnosed eating disorder
  • Insulin-dependent diabetes at trial start
  • Known with type 2 diabetes before pregnancy
  • Children under 18 years
  • Starting up in insulin during the intervention period
  • Diagnosed with lactose intolerance
  • Goes into labor before the intervention is completed
University of Aarhus logoUniversität Aarhus305 aktive klinische Studien zum Erkunden
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Aarhus N

University hospital Aarhus, Skejby, Aarhus N, 8200, Denmark
University of Aarhus, Skejby, Aarhus N, 8200, Denmark