Dietary Management of Gestational Diabetes

Body Composition Clinical Trial

— eMOM  

Official title:

Effects of Guided Dietary Patterns on Metabolic Outcomes in Overweight Pregnant Women With Gestational Diabetes and on Offspring Body Composition

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03681054
• Other study ID #: HUS/1792/2016_2
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 30, 2024
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Birth Weight
• Body Composition
• Diabetes Mellitus
• Diabetes, Gestational
• Dietary Modification
• Glucose Intolerance
• Glucose Intolerance During Pregnancy

Intervention

Other:
• Carbohydrate restricted diet
The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 500 g/d, fish 2 times/wk, low-fat instead of high-fat meat, red meat = 3 times/wk, low-fat instead of high-fat dairy, high-fibre instead of low-fibre grains, vegetable oils (excluding palm oil and coconut oil) and soft margarine instead of animal fats, moderate reduction of carbohydrates (targets for macronutrients: carbohydrates 40 E%; fat 40 E%; protein 20 E%; dietary fiber 32g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: <10 E%; fatty acids: saturated fatty acids < 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)
• Plant-protein based diet
The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 1 kg/d; fish 3/wk; high-fibre grains, mainly rye, oat and barley; plant protein instead of meat protein; low-fat fermented dairy instead of other dairy; rapeseed oil and rapeseed-based margarine instead of other fats; no carbohydrate restriction (targets for macronutrients: carbohydrates 50 E%; fat 30 E%; protein 20 E%; dietary fiber 36g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: <10 E%; fatty acids: saturated fatty acids < 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)

Locations

Country	Name	City	State
Finland	Helsinki university central hospital	Helsinki

Sponsors (6)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Aalto University, City of Helsinki, Finnish Institute for Health and Welfare, UKK Institute, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) in cross-over phase	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system	Study period I: during a 3 day intervention-diet period within gestational weeks 24-28
Primary	Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system	Study period II: during a 14 day period within gestational weeks 34-36
Primary	Child: Neonatal body fat%	Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system	one measure within 0-2 days after birth of the child
Secondary	Mother: Glycaemic variability in crossover phase	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system	Study period I: during a 3 day intervention-diet period within gestational weeks 24-28
Secondary	Mother: Glycaemic variability	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system	Study period II: during a 14 day period within gestational weeks 34-36
Secondary	Percentage of participants on GDM medication		Up to 42 gestational weeks