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

Desconhecido
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT03835208 é um estudo intervencionista para Diabetes gestacional. Seu status atual é: desconhecido. O estudo começou em 25 de fevereiro de 2019 e pretende incluir 15 participantes. Coordenado por a Universidade de Aarhus e deve ser concluído em 1 de maio de 2020. Essas informações foram atualizadas no ClinicalTrials.gov em 30 de setembro de 2019.
Resumo
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.

Descrição detalhada
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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Título oficial

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

Condições médicas
Diabetes gestacional
Outros IDs do estudo
  • HMKvLMK
Número NCT
NCT03835208
Data de início (real)
2019-02-25
Última atualização postada
2019-09-30
Data de conclusão (estimada)
2020-05-01
Inscrição (estimada)
15
Tipo de estudo
Intervencionista
FASE
N/A
Status
Desconhecido
Palavras-chave
gestational diabetes
carbohydrate distribution
high/low carbohydrate
glycemic variability
MAGE
continuous glucose monitoring
Pregnancy in Diabetics
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Estudo cruzado
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalLow-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.
ExperimentalHigh-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.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Feminino
  • 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 logoUniversidade de Aarhus305 estudos clínicos ativos para explorar
Sem dados de contato.
2 Locais do estudo em 1 países

Aarhus N

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