Skip to main content
Clinical Trials/NCT03681054
NCT03681054
Active, not recruiting
Not Applicable

Effects of Guided Dietary Patterns on Metabolic Outcomes in Overweight Pregnant Women With Gestational Diabetes and on Offspring Body Composition

Helsinki University Central Hospital1 site in 1 country42 target enrollmentDecember 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes, Gestational
Sponsor
Helsinki University Central Hospital
Enrollment
42
Locations
1
Primary Endpoint
Child: Neonatal body fat%
Status
Active, not recruiting
Last Updated
7 months ago

Overview

Brief Summary

eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=60) have been diagnosed with gestational diabetes mellitus, and are of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has two two-week study periods that are carried out on approximately gestational weeks 24-28 (period I) and 34-36 (period II). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participants gets at least three personal face-to-face counseling sessions, phone calls, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.

Registry
clinicaltrials.gov
Start Date
December 3, 2018
End Date
December 30, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Saila Koivusalo

Principal Investigator

Helsinki University Central Hospital

Eligibility Criteria

Inclusion Criteria

  • \- Gestational diabetes at enrollment

Exclusion Criteria

  • Gestational weeks exceed 28+6
  • Multiple pregnancy
  • Food allergies or restrictions (other than lactose intolerance)
  • Mother's or father's ethnic background other than Caucasian
  • Type 1 or type 2 diabetes
  • Medication which affects glucose metabolism
  • Cholesterol medication
  • Drug or alcohol abuse
  • Psychiatric illness which affects participation in the study
  • Factors hampering communication (e.g. lack of Finnish skills)

Outcomes

Primary Outcomes

Child: Neonatal body fat%

Time Frame: one measure within 0-2 days after birth of the child

Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system

Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) in cross-over phase

Time Frame: Study period I: during a 3 day intervention-diet period within gestational weeks 24-28

Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)

Time Frame: Study period II: during a 14 day period within gestational weeks 34-36

Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

Secondary Outcomes

  • Mother: Glycaemic variability in crossover phase(Study period I: during a 3 day intervention-diet period within gestational weeks 24-28)
  • Percentage of participants on GDM medication(Up to 42 gestational weeks)
  • Mother: Glycaemic variability(Study period II: during a 14 day period within gestational weeks 34-36)

Study Sites (1)

Loading locations...

Similar Trials