Dietary Management of Gestational Diabetes in Obese Pregnant Women

Body Composition Clinical Trial

— eMOM  

Official title:

Effects of a Standardized Dietary Intake on Metabolic Outcomes in Obese Pregnant Women With Gestational Diabetes and on Offspring Body Composition

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03542071
• Other study ID #: HUS/1792/2016
• Status: Terminated
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: March 23, 2019

Study information

• Verified date: October 2019
• 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=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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 23, 2019
• Est. primary completion date: March 23, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Birth Weight
• Body Composition
• Diabetes Mellitus
• Diabetes, Gestational
• Dietary Modification
• Tissue Glucose

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 55 E%; fat 25 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, Helsinki University, National Institute for Health and Welfare, Finland, UKK Institute

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)	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system	Study period II: during a 14 day period within gestational weeks 23-26
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 III: during a 14 day period within gestational weeks 33-36
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: 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 12-15
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 12-15
Secondary	Mother: Glycaemic variability	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system	Study period II: during a 14 day period within gestational weeks 23-26
Secondary	Mother: Glycaemic variability	Measured with FreeStyle®Libre, Continuous Glucose Monitoring system	Study period III: during a 14 day period within gestational weeks 33-36
Secondary	Percentage of participants on GDM medication		Up to 42 gestational weeks