NCT03835208

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 30, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

February 7, 2019

Last Update Submit

September 27, 2019

Conditions

Diabetes, Gestational

Keywords

gestational diabetescarbohydrate distributionhigh/low carbohydrateglycemic variabilityMAGEcontinuous glucose monitoringPregnancy in Diabetics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Coefficient of variation

    6 days

  • MBG

    6 days

  • Glucagon-like-peptide 1 (GLP1)

    1 hour *2

  • Gastric inhibitory polypeptide (GIP)

    1 hour*2

  • C-peptide

    11 days

Other Outcomes (1)

  • 3-hydroxy-butyrate

    11 days

Study Arms (2)

Low-morning-carbohydrate

EXPERIMENTAL

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-carbohydrate

EXPERIMENTAL

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

Interventions

High/low carbohydrate distributionBEHAVIORAL

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
High-morning-carbohydrateLow-morning-carbohydrate

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University hospital Aarhus

Skejby, Aarhus N, 8200, Denmark

Location

University of Aarhus

Skejby, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Diabetes, GestationalPregnancy in Diabetics

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Per G Ovesen, Dr.Med

    Women's diseases and births

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Each patient will follow 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 8, 2019

Study Start

February 25, 2019

Primary Completion

September 27, 2019

Study Completion

May 1, 2020

Last Updated

September 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)