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

Diabetes, Gestational Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03835208
• Other study ID #: HMKvLMK
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: May 1, 2020
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes, Gestational

Intervention

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.

Locations

Country	Name	City	State
Denmark	University hospital Aarhus	Skejby	Aarhus N
Denmark	University of Aarhus	Skejby	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	3-hydroxy-butyrate	To assess ketonemia	11 days
Primary	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
Secondary	Coefficient of variation	Coefficient of variation	6 days
Secondary	MBG	The average blood glucose, calculated for each two intervention periods using CGM data.	6 days
Secondary	Glucagon-like-peptide 1 (GLP1)	glucagon-like-peptide 1, difference in 1 hour postprandial response	1 hour *2
Secondary	Gastric inhibitory polypeptide (GIP)	Gastric inhibitory polypeptide difference in 1 hour postprandial response	1 hour*2
Secondary	C-peptide	Changes in C-peptide according to carbohydrate distribution	11 days