Dietary Management of Gestational Diabetes

Not Applicable

Active, not recruiting

• Conditions: Birth Weight; Glucose Intolerance During Pregnancy; Dietary Modification; Diabetes, Gestational; Body Composition
• Interventions: Other: Carbohydrate restricted diet; Other: Plant-protein based diet

• Registration Number: NCT03681054
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-21
• Study Start: 2018-12-03
• Primary Completion: 2020-06-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbohydrate restricted diet	Carbohydrate restricted diet	Dietary intervention: moderately carbohydrate restricted diet. Parallel phase starts after study period I and the diet is followed until labor.
Plant-protein based diet	Plant-protein based diet	Dietary intervention: plant-protein based diet, en emphasis on healthy Nordic foods. Parallel phase starts after study period I and the diet is followed until labor.

Primary Outcome Measures

Name	Time	Method
Child: Neonatal body fat%	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	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)	Study period II: during a 14 day period within gestational weeks 34-36	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

Secondary Outcome Measures

Name	Time	Method
Percentage of participants on GDM medication	Up to 42 gestational weeks
Mother: Glycaemic variability in crossover phase	Study period I: during a 3 day intervention-diet period within gestational weeks 24-28	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Mother: Glycaemic variability	Study period II: during a 14 day period within gestational weeks 34-36	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

Trial Locations

Locations (1)

Helsinki university central hospital; 🇫🇮 Helsinki, Finland