Carbohydrates Distribution in Pregnancy Study
Condition: Gestational Diabetes Mellitus in Pregnancy
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

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.
    


Intervention name(s): Intervention Treatment
Intervention type(s): Behavioral
Intervention description(s): Both groups (conventional and treatment) will have the same nutritional composition, with 40% carbohydrates, 20% protein and 40% total fat (preferently monounsaturated fatty acids).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: medical therapy nutrition; meal; carbohydrates; intervention; food intake