Efficiency of following Mediterranean diet recommendations in the real world in the incidence of gestational diabetes mellitus

Efficiency of a dietary intervention based on the Mediterranean diet in the clinical setting in the incidence of gestational diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13389832

Enrollment

873

Registered

2016-10-26

Start date

2016-11-01

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus Nutritional, Metabolic, Endocrine Gestational Diabetes Mellitus

Interventions

A nutritional intervention based on the Mediterranean diet will be given to all pregnant women attending the study hospital in the first gestational visit (gestational weeks 8 to 12).

oral glucose tolerance test with 75 g of glucose for identification of gestational diabetes with the IADPSG criteria, nutritional questionnaire and blood and urine sample. Visits 3-4 (

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Pregnant women older than 18 with fasting glucose levels < 92 mg/dl in the first gestational visit (gestational week 8 to 12).

Exclusion criteria

Exclusion criteria: 1. Pregnant women with fasting glucose levels >92 mg/dl in the first gestational visit (gestational week 8 to 12) 2. Intolerance/allergy to nuts or olive oil, multiple pregnancy, and any disease or medical treatment that can have an effect on the intervention. Women with specific nutritional treatments

Design outcomes

Primary

Measure	Time frame
Incidence of gestational diabetes mellitus at 24-28 gestational weeks. The diagnosis of gestational diabetes mellitus will be established with a 75 g oral glucose tolerance test according to the criteria o IADPSG 2009 and WHO 2013.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 04/12/2018: Participants were enrolled at 8-12 gestational weeks (GWs) (visit 0) and were followed-up at GWs 12-14 (visit 1), 24-28 (visit 2), 34-36 (visit 3-4) and delivery (visit 5), as well as at 12 weeks post partum (visit 6): 1. The diagnosis of GDM was established with a 75 g oral glucose tolerance test according to the criteria of IADPSG 2009 and WHO 2013 in visit 2. 2. Pregestational body weight (BW) was self-referred and registered at Visit 1. BW in each visit (1,2, 3 and 4) was measured without shoes and with lightweight clothes. Weight gain was evaluated at 24-28 and 36-38 GW (in relation to BW at Visit 1) 3. Blood pressure was measured with an adequate armlet when the participants had been seated for 10 minutes 4. Need of insulin therapy was registered from endocrinology clinical records after GDM diagnosis at visit 2 (Visits 2, 3 and 4) 5. Pregnancy-induced hypertension (=140mmHg systolic blood pressure/90 mmHg diastolic blood pressure after 20 GW) 6. Preeclampsia (=140mmHg systolic/90 mmHg diastolic with proteinuria =300 mg in 24-h after 20 GW; albuminuria (proteinuria= 300 mg in 24-h with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) 7. UTIs (number of events requiring antibiotic treatment) recorded at each visit 8. Type of delivery (vaginal, instrumental or caesarean section) and perineal trauma (any degree of spontaneous tears and episiotomy) recorded from obstetric clinical records 9. Gestational age at birth, prematurity (<37 GW), birth weight (g), height (cm) and percentiles, LGA, SGA according to national charts, and NICU admissions were registered from clinical records. Previous secondary outcome measures: Percentage of women with a weight gain at the last gestational visit (weeks 37-40)	—

Measure

Time frame

Current secondary outcome measures as of 04/12/2018: Participants were enrolled at 8-12 gestational weeks (GWs) (visit 0) and were followed-up at GWs 12-14 (visit 1), 24-28 (visit 2), 34-36 (visit 3-4) and delivery (visit 5), as well as at 12 weeks post partum (visit 6): 1. The diagnosis of GDM was established with a 75 g oral glucose tolerance test according to the criteria of IADPSG 2009 and WHO 2013 in visit 2. 2. Pregestational body weight (BW) was self-referred and registered at Visit 1. BW in each visit (1,2, 3 and 4) was measured without shoes and with lightweight clothes. Weight gain was evaluated at 24-28 and 36-38 GW (in relation to BW at Visit 1) 3. Blood pressure was measured with an adequate armlet when the participants had been seated for 10 minutes 4. Need of insulin therapy was registered from endocrinology clinical records after GDM diagnosis at visit 2 (Visits 2, 3 and 4) 5. Pregnancy-induced hypertension (=140mmHg systolic blood pressure/90 mmHg diastolic blood pressure after 20 GW) 6. Preeclampsia (=140mmHg systolic/90 mmHg diastolic with proteinuria =300 mg in 24-h after 20 GW; albuminuria (proteinuria= 300 mg in 24-h with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) 7. UTIs (number of events requiring antibiotic treatment) recorded at each visit 8. Type of delivery (vaginal, instrumental or caesarean section) and perineal trauma (any degree of spontaneous tears and episiotomy) recorded from obstetric clinical records 9. Gestational age at birth, prematurity (<37 GW), birth weight (g), height (cm) and percentiles, LGA, SGA according to national charts, and NICU admissions were registered from clinical records. Previous secondary outcome measures: Percentage of women with a weight gain at the last gestational visit (weeks 37-40)

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Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026