Clinical trial NCT03681054: Dietary Management of Gestational Diabetes
Official title: Effects of Guided Dietary Patterns on Metabolic Outcomes in Overweight Pregnant Women With Gestational Diabetes and on Offspring Body Composition
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes, Gestational
Dietary Modification
Glucose Intolerance During Pregnancy
Body Composition
Birth Weight
Keywords: Nutrition
Dietary Counseling
Diet
Pregnancy
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: 2018-09-21
Enrollment: 42
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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=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.


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)

Primary 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 24-28
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 34-36
measure: Child: Neonatal body fat%
timeFrame: one measure within 0-2 days after birth of the child
Secondary outcomes:
measure: Mother: Glycaemic variability in crossover phase
timeFrame: Study period I: during a 3 day intervention-diet period within gestational weeks 24-28
measure: Mother: Glycaemic variability
timeFrame: Study period II: during a 14 day period within gestational weeks 34-36
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 obs and gyn/Helsinki University Hospital
name: Seppo Heinonen, prof
role: STUDY_DIRECTOR
References: