An interventional study of High/low carbohydrate distribution in Diabetes, Gestational, sponsored by University of Aarhus. Status unknown at 2 sites in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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 Continuous glucose monitoring (CGM) for day-to-day monitoring of glycemic variability, including frequency, duration, and magnitude of hyperglycaemic fluctuations.
Carbohydrate is the macronutrient that has the greatest impact on postprandial blood glucose response. Despite this, there is a current lack of evidence of how the carbohydrate intake should be distributed throughout a day.
This study aims to investigate whether high-morning carbohydrate intake (HMK) compared to low-morning carbohydrate intake (LMK) affects glycemic variability in GDM patients.
Design:
Randomized crossover intervention study comparing two intervention diets; high-morning carbohydrate intake (HMK) versus low-morning carbohydrate intake (LMK) each of 3 days duration with four-day washout.
Diet intervention: Both intervention diets have the same calorie content and contain the same amounts of protein, carbohydrate and fat for the individual patient, but the distribution of carbohydrate and energy differs throughout the day.
Dietary intake will be estimated through 24-hour recall interview by trained dietitians. Estimation of actual intake is validated by photos of every main meal.
All data will be collected and stored in RedCap to secure data checks.
Statistics Analysis and sample size:
Power calculation on primary outcome MAGE- estimates 15 patients for inclusion with a power of 80%, SD 0,6mmol/l, a significance level of 0,05 and a MIREDIF of 0,5 mmol/l. 15 persons include an expected dropout rate at 20%.
Non-parametric tests will be used for the secondary and primary outcome.
Perspective:
A future perspective of this study is to improve the current treatment in regards to nutritional recommendations. Thus, the study could potentially contribute with the knowledge that would clarify the carbohydrate recommendations and improve the glycemic control of patients with GDM and therefore be beneficial to patients' future treatment and prevent complications and development of type 2 diabetes in the child.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 15 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: High/low carbohydrate distribution
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.
Behavioral: 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.
Also known as: High-energy breakfasting compared with high-energy dinner
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.
Time frame: 6 days
Coefficient of variation
Coefficient of variation
Time frame: 6 days
MBG
The average blood glucose, calculated for each two intervention periods using CGM data.
Time frame: 6 days
Glucagon-like-peptide 1 (GLP1)
glucagon-like-peptide 1, difference in 1 hour postprandial response
Time frame: 1 hour *2
Gastric inhibitory polypeptide (GIP)
Gastric inhibitory polypeptide difference in 1 hour postprandial response
Time frame: 1 hour*2
C-peptide
Changes in C-peptide according to carbohydrate distribution
Time frame: 11 days
3-hydroxy-butyrate
To assess ketonemia
Time frame: 11 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of Aarhus