Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/10/2016
Date assigned
26/10/2016
Last edited
30/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gestational Diabetes Mellitus (GDM) is a heath condition that occurs during pregnancy where the body becomes unable to produce enough insulin – a hormone that helps to control the amount of sugar in the blood – to meet the extra needs during pregnancy. The condition usually resolves itself after the mother has given birth. There is growing interest in GDM due to an increase in the number of women being diagnosed with the condition. It can have harmful consequences for both mother and baby. The mother, for example, can develop gestational hypertension (high blood pressure) and pre-eclampsia (a condition that causes high blood pressure and can lead to some serious pregnancy complications if left untreated). GDM can also the baby to grow larger than usual (macrosomia) , which can result in a difficult delivery and the need for induced labour or caesarean section, low blood sugar levels (hypoglycemia), high insulin levels (hyperinsulinemia) shoulder dystocia (a condition where it is difficult to deliver the shoulders of the baby after the head has already been delivered), and an increased risk of obesity (being very overweight) and type 2 diabetes later in life. A significant number of women who have had GDM will develop type 2 diabetes later in life and may be at increased risk of cardiovascular (for example heart) disease. Researchers have looked at the effect of the Mediterranean diet on the prevention of GDM, providing free olive oil and nuts to patients (study record ISRCTN84389045). There is some preliminary data showing a decrease in the number of women developing GDM after eating a Mediterranean diet(with recommendations of reducing fat intake to < 30% and saturated fat < 10% of total intake). This study is looking at whether an universal nutritional recommendation based on the Mediterranean diet in the real clinical setting (for example, a hospital) , with the usual obstetric and endocrinological follow-up will be as effective as when tested as part of a clinical study.

Who can participate?
Pregnant women over the age of 18 with high blood glucose levels.

What does the study involve?
All participants are given advise on diet to be followed during their pregnancy. Recommendations include having fresh vegetables at both lunch and dinner every day and up to 3 pieces of fresh fruit every day. They are also advised to use extra olive oil for cooking and salad dressings, to have nuts every day and to eat 3 portions of semi-skimmed dairy products. They are also told to eat wholegrain cereals and to avoid biscuits, pastries and cakes. They are encouraged to partake of moderate physical activity (for example, to climb four floors of steps four times a day) every day. They are assessed during their usual visits to the Obstetrics department. During their first visit, they are asked to fill in a nutritional questionnaire and give blood samples as well as sit a medical interview. They then receive nutritional recommendations during their second visit and are tested throughout their pregnancy for GDM and to check whether they are following the dietary advice.

What are the possible benefits and risks of participating?
All the participants will gain nutritional education beneficial for the development of their pregnancy. There are no side effects.

Where is the study run from?
Hospital Clínico San Carlos, Madrid (Spain)

When is the study starting and how long is it expected to run for?
February 2016 to November 2017

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Nuria García de la Torre Lobo

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nuria García de la Torre Lobo

ORCID ID

http://orcid.org/0000-0003-3546-9231

Contact details

Servicio de Endocrinología y Nutrición.
Hospital Clínico San Carlos. C/Profesor Martín Lagos s/n.
Madrid
28040
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

The efficacy of a nutritional intervention in the clinical setting based on the mediterranean diet is not inferior to the results obtained from a clinical trial (ISRCTN84389045) in the incidence of gestational diabetes mellitus.

Ethics approval

CEIC Hospital Clínico San Carlos, 08/11/2016, ref: 16/442-E

Study design

Unicentric prospective and interventional

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

See additional files

Condition

Gestational Diabetes Mellitus

Intervention

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).

All participants will have the usual follow-up visits in the Obstetrics department, and also in the Endocrinology department in case gestational diabetes is diagnosed.

Visit 0: between 8-12 gestational weeks: Consent signature, medical interview, blood sample, and nutritional questionnaire.
Visit 1: one week later: inclusion criteria compliance, blood sample, and nutritional recommendations.
Visit 2: Between 24-28 gestational weeks; 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 (and 4’, if needed): Gestational weeks 28 to 38 if they are diagnosed with gestational diabetes for the usual follow up in the Endocrinology department.
Visit 5: 38 gestational week: nutritional questionnaire, blood and urine sample.
Visit 6: 12 weeks postpartum: clinical evaluation, nutritional questionnaire and blood sample.

The intervention will include these main recommendations:
1. To have fresh vegetables at lunch and dinner daily (any type of vegetables)
2. To have fresh fruit for dessert at lunch and dinner daily ( maximum 3 portions a day, avoid juices)
3. To use extra virgin olive oil daily for cooking and dressings
4. To have nuts daily (as snacks and for salads)
5. To have 3 portions of semi skimmed dairies daily
6. To have wholegrain cereals instead of whites. To avoid biscuits, pastries, and cakes
7. To perform moderate physical activity (to climb four floors of steps four times daily)

Intervention type

Phase

Drug names

Primary outcome measures

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 outcome measures

Percentage of women with a weight gain at the last gestational visit (weeks 37-40)

Overall trial start date

01/02/2016

Overall trial end date

01/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1514

Participant 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

Recruitment start date

01/11/2016

Recruitment end date

01/11/2017

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Clínico San Carlos
calle Profesor Martín Lagos s/n
Madrid
28040
Spain

Sponsor information

Organisation

The Health Research Institute of San Carlos (Instituto de Investigación Sanitaria San Carlos)

Sponsor details

San Carlos Hospital. (Hospital Clínico San Carlos)
c/Profesor Martín Lagos s/n
Madrid
28040
Spain

Sponsor type

Research organisation

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Recruitment will be finished in November 2017. Last patients will give birth in July 2018, so we will publish our data in an original article by the end of 2018.

IPD sharing plan:
Please request access to participant level data by emailing nurialobo@hotmail.com

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/08/2017: Ethics approval has been added. 23/11/2016: The participant information sheet has been uploaded.