Status:
COMPLETED
Carbohydrates Distribution in Pregnancy Study
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Hospital Arnau de Vilanova
Institut de Recerca Biomèdica de Lleida
Conditions:
Gestational Diabetes Mellitus in Pregnancy
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03378908
Start Date
February 1 2018
End Date
September 1 2021
Last Update
August 4 2022
Active Locations (2)
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1
Berta Soldevila
Badalona, Barcelona, Spain, 08916
2
Marta Hernández
Lleida, Spain, 25196