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

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ClinicalTrials.gov Identifier: NCT03835208
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
University of Aarhus

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetes, Gestational Behavioral: High/low carbohydrate distribution Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each patient will live after the HMK and LMK diet in a period of 2x3 days in randomized order with a four day washout between. The order of the two diets will be assigned randomly.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 4, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-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.

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.
Other Name: High-energy breakfasting compared with high-energy dinner

Experimental: High-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.

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.
Other Name: High-energy breakfasting compared with high-energy dinner




Primary Outcome Measures :
  1. mean amplitude of glucose excursions (MAGE) [ Time Frame: 6 days ]
    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.


Secondary Outcome Measures :
  1. Coefficient of variation [ Time Frame: 6 days ]
    Coefficient of variation

  2. Glucose-AUC0-180 min [ Time Frame: 6 days ]
    postprandial glucose response

  3. MBG [ Time Frame: 6 days ]
    The average blood glucose, calculated for each two intervention periods using CGM data.

  4. Glucagon-like-peptide 1 (GLP1) [ Time Frame: 1 hour *2 ]
    glucagon-like-peptide 1, difference in 1 hour postprandial response

  5. Gastric inhibitory polypeptide (GIP) [ Time Frame: 1 hour*2 ]
    Gastric inhibitory polypeptide difference in 1 hour postprandial response

  6. C-peptide [ Time Frame: 11 days ]
    Changes in C-peptide according to carbohydrate distribution


Other Outcome Measures:
  1. 3-hydroxy-butyrate [ Time Frame: 11 days ]
    To assess ketonemia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational diabetes mellitus diagnosed according to current Danish practice (2-hour oral glucose tolerance test (OGTT) > 9.0 mmol/l)
  • Non-insulin depending
  • Adult 18+ years
  • Gestational age weeks 30-34 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835208


Contacts
Contact: Per Glud Ovesen, Dr.Med 78453329 per.ovesen@rm.dk
Contact: Ulla K Opstrup, Professor 22370857 ext +45 ulla@opstrup.dk

Locations
Denmark
University hospital Aarhus Recruiting
Skejby, Aarhus N, Denmark, 8200
Contact: Per G Ovesen, Dr.Med    784533329 ext +45    per.oversen@rm.dk   
Contact: Ulla K Opstrup, professor    22370857 ext +45    ulla@opstrup.dk   
Principal Investigator: Louise Rasmussen, Student         
Principal Investigator: Maria L Christensen, Student         
Sub-Investigator: Charlotte W Poulsen, Dietitian         
University Hospital Aarhus Enrolling by invitation
Skejby, Aarhus N, Denmark, 8200
University of Aarhus Recruiting
Skejby, Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
University of Copenhagen
Investigators
Study Director: Per G Ovesen, Dr.Med Women's diseases and births

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03835208     History of Changes
Other Study ID Numbers: HMKvLMK
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
gestational diabetes
carbohydrate distribution
high/low carbohydrate
glycemic variability
MAGE
continuous glucose monitoring
Pregnancy in Diabetics

Additional relevant MeSH terms:
Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases