Dietary Management of Gestational Diabetes in Obese Pregnant Women

Not Applicable

Terminated

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

• Registration Number: NCT03542071
• 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=50) have early gestational diabetes mellitus (diagnosed before gestational weeks 13), are obese (BMI \>30 kg/m²) and 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 three two-week study periods that are carried out on approximately gestational weeks 13-14 (period I), 24-25 (period II) and 34-35 (period III). 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 participant gets at least five personal counselling sessions, 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: 2018-04-03
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-05-31
• Study Start: 2018-07-20
• Primary Completion: 2019-03-23
• Study Completion: 2019-03-23
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-22
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

• Early gestational diabetes (pregnancy weeks 10-15)
• BMI ≥ 30 kg/m2
• Pregnancy confirmed with ultrasound screening

Exclusion Criteria

• Multiparous 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 study
• Factors hampering communication (e.g. lack of Finnish skills)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
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.

Primary Outcome Measures

Name	Time	Method
Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)	Study period III: during a 14 day period within gestational weeks 33-36	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
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

Secondary Outcome Measures

Name	Time	Method
Mother: Glycaemic variability in crossover phase	Study period I: during a 3 day intervention-diet period within gestational weeks 12-15	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Mother: Glycaemic variability	Study period III: during a 14 day period within gestational weeks 33-36	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Percentage of participants on GDM medication	Up to 42 gestational weeks
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 12-15	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

Trial Locations

Locations (1)

Helsinki university central hospital; 🇫🇮 Helsinki, Finland