Clinical trial NCT03542071: Dietary Management of Gestational Diabetes in Obese Pregnant Women
Official title: Effects of a Standardized Dietary Intake on Metabolic Outcomes in Obese Pregnant Women With Gestational Diabetes and on Offspring Body Composition
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes, Gestational
Dietary Modification
Tissue Glucose
Body Composition
Birth Weight
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Aalto University
name: Finnish Institute for Health and Welfare
name: City of Helsinki
name: UKK Institute
First posted: 2018-05-31
Enrollment: 2
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)
timeFrame: Study period II: during a 14 day period within gestational weeks 23-26
measure: Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)
timeFrame: Study period III: during a 14 day period within gestational weeks 33-36
measure: Child: Neonatal body fat%
timeFrame: one measure within 0-2 days after birth of the child
Secondary outcomes:
measure: Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) in cross-over phase
timeFrame: Study period I: during a 3 day intervention-diet period within gestational weeks 12-15
measure: Mother: Glycaemic variability in crossover phase
timeFrame: Study period I: during a 3 day intervention-diet period within gestational weeks 12-15
measure: Mother: Glycaemic variability
timeFrame: Study period II: during a 14 day period within gestational weeks 23-26
measure: Mother: Glycaemic variability
timeFrame: Study period III: during a 14 day period within gestational weeks 33-36
measure: Percentage of participants on GDM medication
timeFrame: Up to 42 gestational weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki university central hospital
Study officials:
affiliation: Head of department of obst et gyn / Helsinki Unversity Hospital
name: Seppo Heinonen, prof
role: STUDY_DIRECTOR
References: