Gestational Diabetes Mellitus in Pregnancy
Conditions
Keywords
medical therapy nutrition, meal, carbohydrates, intervention, food intake
Brief summary
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.
Interventions
BEHAVIORALIntervention Treatment
Both groups (conventional and treatment) will have the same nutritional composition, with 40% carbohydrates, 20% protein and 40% total fat (preferently monounsaturated fatty acids).
Sponsors
Hospital Arnau de Vilanova
Institut de Recerca Biomèdica de Lleida
Universitat de Lleida
Fundació Institut Germans Trias i Pujol
Germans Trias i Pujol Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Glycemic profile will be collected with a blind-sensor during the study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preprandial ketonemia | 4 weeks (2 weeks with the conventional treatment and 2 weeks with the intervention treatment) | Before the 3 main meals every day. |
| Glycemic profile below pregnancy target capillary blood glucose concentration | 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment) | Self monitoring blood glucose levels: pre meals \< 90 mg/dL, 1 hour post meals \<140mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Newborn body weight adjusted for gestational age (national standardized charts) | At delivery | Large for gestational age \> 90th centile, small for gestational age \< 10th centile |
| Newborn hypoglycemia | 48 hours from delivery | Serum glycemia \<40 mg/dL in the first 48 hours of life |
| Area under the curve of interstitial glucose levels | Time Frame: 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment) | Blinded continuous glucose monitoring data, iPro2, Medtronic (r)): diurnal (from 7 am to 11 pm) and nocturnal (from 11pm to 7 am) |
| Point-of-care glycated hemoglobin (HbA1c) | Every 2 weeks from the date of randomization until the last visit of the study | DCA Vantage Analyzer, Siemens ® |
| Postpartum glucose tolerance of the mother | 6 weeks after delivery | Plasma glucose levels fasting and 120 minutes after a 75 g oral glucose load |
| Fetal Macrosomia | Through study completion, 4 weeks | US assessed fetal weight, adjusted for national standardized charts |
Countries
Spain
Outcome results
None listed