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

Sconosciuto
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La sperimentazione clinica NCT03835208 è uno studio interventistico per Diabete gestazionale, attualmente sconosciuto. Avviato il 25 febbraio 2019, prevede di arruolare 15 partecipanti. Sotto la guida di l'Università di Aarhus, dovrebbe concludersi entro il 1 maggio 2020. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 30 settembre 2019.
Sommario breve
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.

Descrizione dettagliata
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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Titolo ufficiale

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

Patologie
Diabete gestazionale
Altri ID dello studio
  • HMKvLMK
Numero NCT
NCT03835208
Data di inizio (effettiva)
2019-02-25
Ultimo aggiornamento pubblicato
2019-09-30
Data di completamento (stimata)
2020-05-01
Arruolamento (previsto)
15
Tipo di studio
Interventistico
FASE
N.D.
Stato
Sconosciuto
Parole chiave
gestational diabetes
carbohydrate distribution
high/low carbohydrate
glycemic variability
MAGE
continuous glucose monitoring
Pregnancy in Diabetics
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
Studio incrociato
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleLow-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.
SperimentaleHigh-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.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Femmina
  • 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 logoUniversità di Aarhus305 studi clinici attivi da esplorare
University of Copenhagen logoUniversità di Copenaghen220 studi clinici attivi da esplorare
Nessun dato di contatto
2 Centri dello studio in 1 paesi

Aarhus N

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