Carbohydrates Distribution in Pregnancy Study

Study Overview
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Brief Summary
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Hypothesis: Patients with Gestational Diabetes Mellitus (GDM) have a high risk to develop complications during pregnancy, puerperium and in the newborn. At present there are not scientific evidences about the optimal distribution of meals in the medical nutrition therapy (MNT) and their relationship with glycemic control. Aim: To explore and compare ketonemia and glycemic profile in patients with GDM that follow a MNT distributed in 6 or 3 meals. Besides, we want to explore the differences between both treatments in glucose dynamics. Methods: The study design is a randomized, crossover and multicentric trial. A sample of 10 patients with GDM will be recruited in the Department of Endocrinology and Nutrition from both centres. In a randomized manner patients will follow the conventional treatment (a carbohydrate-controlled diet distributed in 6 meals: 3 main meals and 3 snacks) and the intervention treatment (a carbohydrate-controlled diet distributed in 3 meals: breakfast, lunch and dinner). They will be randomized to begin with one of the two treatments, and after two weeks they will be switched to the other treatment. Patients will wear a blinded continuous glucose monitoring device (iPro2-TM, Medtronic) during the entire study period. Inclusion criteria: Women with GDM diagnosed in 24-28 weeks. Age 18-40 years. Pregnancy age of 28-32 weeks. Caucasian. Body mass index ≤ 35 Kg/m2. Exclusion criteria: Unability to understand the dietary recommendations and/or to perform self-management of glycemia, ketonuria or ketonemia. A low adherence to MNT. Problems with written and/or oral communication. Presence of comorbidities other than obesity, hypertension and dyslipidemia. Insulin-need criteria within 3 first days of the beginning of the study (fasting glucose ≥90mg/dL, postprandial glucose 1-hour ≥140mg/dL). Clinical and sociodemographic variables will be assessed. Dietary records and blood samples will be collected. Daily basal ketonuria and ketonemia before each meal will be assessed. Glycemic profile will be collected with a blind-sensor during the four weeks of the intervention study. Generalized linear model analysis will be performed. Statistical power will be 80% and significance level will be set at 0.05. Written informed consent will be collected from all participants.

Official Title
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Medical Nutrition Therapy in Gestational Diabetes Mellitus: Comparison of Different Number of Meals. A Pilot Study

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Behavioral: Intervention Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with GDM diagnosed in 24-28 weeks. Age 18-40 years. Pregnancy age of 28-32 weeks. Caucasian. Body mass index ≤ 35Kg/m2. Firs-time mother. Exclusion Criteria: Disability to understand the dietary recommendations and/or to perform self-management of glycemia, ketonuria or ketonemia. A low adherence to MNT. Problems with write and oral communication. Other comorbidities differed of obesity, hypertension and dyslipidemia. Insulin criteria within 3 first days of study (fasting glucose ≥90mg/dL, postprandial glucose 1-hour ≥140mg/dL).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Treatment 6 meals<br>Diet will be distributed with 6 meals (breakfast, lunch, dinner and 3 snacks). This is the usual diet prescribed for women with GDM at the Department of Endocrinology and Nutrition of both Centers. Energy intake distribution: 25% breakfast, 5% snack, 30% lunch, 10% snack, 25% dinner and 5% snack. | |
| Experimental: Intervention Treatment 3 meals<br>Diet will be distributed in 3 meals (breakfast, lunch and dinner). Each meal will consist of the addition of the conventional meal and the next snack. Energy intake will be distributed: 30% breakfast (25% breakfast + 5% snack), 40% lunch (30% lunch + 10% snack) and 30% dinner (25% dinner and 5% snack). | Behavioral: Intervention Treatment<br>* Both groups (conventional and treatment) will have the same nutritional composition, with 40% carbohydrates, 20% protein and 40% total fat (preferently monounsaturated fatty acids).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preprandial ketonemia | Before the 3 main meals every day. | 4 weeks (2 weeks with the conventional treatment and 2 weeks with the intervention treatment) | 
| Glycemic profile below pregnancy target capillary blood glucose concentration | Self monitoring blood glucose levels: pre meals < 90 mg/dL, 1 hour post meals <140mg/dL | 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of interstitial glucose levels | Blinded continuous glucose monitoring data, iPro2, Medtronic (r)): diurnal (from 7 am to 11 pm) and nocturnal (from 11pm to 7 am) | Time Frame: 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment) | 
| Fetal Macrosomia | US assessed fetal weight, adjusted for national standardized charts | Through study completion, 4 weeks | 
| Newborn body weight adjusted for gestational age (national standardized charts) | Large for gestational age > 90th centile, small for gestational age < 10th centile | At delivery | 
| Newborn hypoglycemia | Serum glycemia <40 mg/dL in the first 48 hours of life | 48 hours from delivery | 
| Postpartum glucose tolerance of the mother | Plasma glucose levels fasting and 120 minutes after a 75 g oral glucose load | 6 weeks after delivery | 
| Point-of-care glycated hemoglobin (HbA1c) | DCA Vantage Analyzer, Siemens ® | Every 2 weeks from the date of randomization until the last visit of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbohydrates, medical therapy nutrition, meal, intervention, food intake