Dietary Management of Gestational Diabetes in Obese Pregnant Women

NCT03542071 | Terminated

• 1 other identifier: HUS/1792/2016
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) in cross-over phase

  Study period I: during a 3 day intervention-diet period within gestational weeks 12-15

• Mother: Glycaemic variability in crossover phase

  Study period I: during a 3 day intervention-diet period within gestational weeks 12-15

• Mother: Glycaemic variability

  Study period II: during a 14 day period within gestational weeks 23-26

• Mother: Glycaemic variability

  Study period III: during a 14 day period within gestational weeks 33-36

• Percentage of participants on GDM medication

  Up to 42 gestational weeks

Study Arms (2)

Carbohydrate restricted diet

EXPERIMENTAL

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

Other: Carbohydrate restricted diet

Plant-protein based diet

EXPERIMENTAL

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.

Other: Plant-protein based diet

Interventions

Carbohydrate restricted diet OTHER

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)

Carbohydrate restricted diet

Plant-protein based diet OTHER

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)

Plant-protein based diet

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Early gestational diabetes (pregnancy weeks 10-15)
• BMI ≥ 30 kg/m2
• Pregnancy confirmed with ultrasound screening

You may not qualify if:

• 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)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator
• Aalto University: collaborator
• Finnish Institute for Health and Welfare: collaborator
• City of Helsinki: collaborator
• UKK Institute: collaborator

Study Sites (1)

Helsinki university central hospital

Helsinki, Finland

Location

MeSH Terms

Conditions

Diabetes, Gestational; Birth Weight

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Seppo Heinonen, prof

  Head of department of obst et gyn / Helsinki Unversity Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: May 31, 2018
• Study Start: July 20, 2018
• Primary Completion: March 23, 2019
• Study Completion: March 23, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)