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Effect of Carbohydrate Distribution on Blood Glucose in Women With Gestational Diabetes Mellitus (GDM) ١٥

غير معروف
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT03835208 هي دراسة تدخُّلية لـالسكري الحملي وهي غير معروف. بدأت في ٢٠ جمادى الآخرة ١٤٤٠ هـ مع خطة لتجنيد ١٥ مشاركًا. يقودها جامعة آرهوس، ومن المتوقع اكتمالها بحلول ٨ رمضان ١٤٤١ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١ صفر ١٤٤١ هـ.
الملخص
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.

وصف مفصل
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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العنوان الرسمي

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

الحالات الطبية
السكري الحملي
معرّفات دراسة أخرى
  • HMKvLMK
NCT معرّف
NCT03835208
تاريخ البدء (فعلي)
2019-02-25
آخر تحديث مُنشور
2019-09-30
تاريخ الاكتمال (المقدر)
2020-05-01
عدد المشاركين المخطط لهم
١٥
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
غير معروف
الكلمات الرئيسية
gestational diabetes
carbohydrate distribution
high/low carbohydrate
glycemic variability
MAGE
continuous glucose monitoring
Pregnancy in Diabetics
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
تصميم متقاطع
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
تجريبيةLow-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.
تجريبيةHigh-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.
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
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
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
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
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
أنثى
  • 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 logoجامعة آرهوس305 دراسات نشطة للاستكشاف
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2 مواقع الدراسة في 1 بلدان

Aarhus N

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