Dietary Management of Gestational Diabetes in Obese Pregnant Women (eMOM)

Helsinki University Central Hospital (HUCH)

Status: Terminated

Conditions: Birth Weight; Diabetes, Gestational; Dietary Modification; Tissue Glucose; Body Composition

Treatments: Other: Plant-protein based diet; Other: Carbohydrate restricted diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03542071

HUS/1792/2016

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups

Carbohydrate restricted diet

Experimental group

Description:

Dietary intervention: moderately carbohydrate restricted diet. Parallel phase starts after study period I and the diet is followed until labor.

Treatment:

Other: Carbohydrate restricted diet

Plant-protein based diet

Experimental group

Description:

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.

Treatment:

Other: Plant-protein based diet