Clinical trial NCT03378908: Carbohydrates Distribution in Pregnancy Study
Official title: Medical Nutrition Therapy in Gestational Diabetes Mellitus: Comparison of Different Number of Meals. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Keywords: medical therapy nutrition
meal
carbohydrates
intervention
food intake
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Arnau de Vilanova
name: Institut de Recerca Biomèdica de Lleida
name: Universitat de Lleida
name: Fundació Institut Germans Trias i Pujol
First posted: 2017-12-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Preprandial ketonemia
timeFrame: 4 weeks (2 weeks with the conventional treatment and 2 weeks with the intervention treatment)
measure: Glycemic profile below pregnancy target capillary blood glucose concentration
timeFrame: 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment)
Secondary outcomes:
measure: Area under the curve of interstitial glucose levels
timeFrame: Time Frame: 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment)
measure: Fetal Macrosomia
timeFrame: Through study completion, 4 weeks
measure: Newborn body weight adjusted for gestational age (national standardized charts)
timeFrame: At delivery
measure: Newborn hypoglycemia
timeFrame: 48 hours from delivery
measure: Postpartum glucose tolerance of the mother
timeFrame: 6 weeks after delivery
measure: Point-of-care glycated hemoglobin (HbA1c)
timeFrame: Every 2 weeks from the date of randomization until the last visit of the study
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Berta Soldevila
state: Barcelona
city: Lleida
country: Spain
facility: Marta Hernández
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Didac Mauricio, MD PHD
role: STUDY_DIRECTOR
References: