Plain English Summary
Background and study aims
Diabetes mellitus is a life-long condition where a person is unable to control their blood sugar levels. There are two main types of diabetes, type 1 (around 10% of cases) and type 2. In type 1 diabetes (T1DM) the immune system attacks specialised cells in the pancreas called β-cells (which are responsible for producing the hormone insulin). This means that the sufferer is unable to produce enough insulin to effectively control their blood sugar levels and so regularly inject insulin in order to keep their blood sugar levels in a healthy range. When insulin is made in the pancreas, another molecule called C-peptide is also produced. C-peptide does not affect blood sugar, but as it is found in equal amounts to insulin, testing C-peptide levels is a good way of finding out how much insulin there is in the body. Some studies have shown that fatty acids may be able to protect the pancreas, as well as helping promote normal growth of a baby during pregnancy. The aim of this study is to find out what the effects are when pregnant women with type 1 diabetes take fatty acid supplements on C-peptide and blood sugar control.
Who can participate?
Pregnant women aged between 18 and 40 with type 1 diabetes.
What does the study involve?
Women are randomly allocated to one of two groups. Those in the first group take supplements containing fatty acids (eicosapentanoic acid (EPA) and docosahexanoic acid (DHA)) at meal times from the start of the study (when they are nine weeks pregnant) until they have their baby. Those in the second group take supplements containing a placebo (dummy pill) at meal times from the start of the study until delivery. At the start of the study and then when the women are 20 and 30 weeks pregnant, and at the time of delivery, blood samples are taken to assess how well they are managing their blood sugar levels.
What are the possible benefits and risks of participating?
Women who take the fatty acid supplements may benefit from lower levels of C-peptide, which could mean that they need to take less insulin. There is also evidence that taking fatty acids during pregnancy could aid the development of their baby’s brain. There are no notable risks involved with participating.
Where is the study run from?
Department of Obstetrics and Gynecology School of Medicine Zagreb (Croatia)
When is the study starting and how long is it expected to run for?
December 2013 to September 2019
Who is funding the study?
Ministry of Science, Education and Technology of the Republic of Croatia (Croatia)
Who is the main contact?
Prof. Josip Djelmis
The impact of EPA and DHA supplementation on c-peptide preservation in type 1 diabetic pregnant women
The aim of this study is to find the impact of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA) on secretion fasting C-peptide in pregnant women with type-1 diabetes.
Ethics Committee School of Medicine University of Zagreb, 12/12/2013, ref: 021-1/206 A-13
Randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Type 1 diabetes mellitus
Participants are randomly allocated to one of two groups:
Intervention group: Participants take capsules containing 60mg EPA (eicosapentanoic) and 308 mg DHA (docosahexanoic acid) twice a day at mealtimes during pregnancy, from baseline (9th week of gestation) until delivery.
Control group: Participants take capsules containing a placebo twice a day at mealtimes during pregnancy, from baseline (9th week of gestation) until delivery.
Throughout the study, participants attend standard visits at Clinics at 20th week of gestation, 30th week of gestation and at delivery. At these visits, samples of blood are taken in order to measure levels of fasting C-peptide concentration, level of FPG and HbA1c.
Primary outcome measures
FC-peptide concentration is measured by the electrochemiluminescence immunoassay “ECLIA” at baseline, 20 weeks gestation, 30 weeks gestation and at delivery.
Secondary outcome measures
1. Glycated hemoglobin (HbA1c) is measured from blood samples taken at baseline, 20 weeks gestation, 30 weeks gestation and at delivery
2. Fasting plasma glucose (FPG) is measured using the fasting plasma glucose test using blood samples taken at baseline, 20 weeks gestation, 30 weeks gestation and at delivery
3. Birth weight of infants is measured by pediatrics after delivery
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Pregnant women
2. Diagnosis of type 1 diabetes
3. Provision of informed consent
4. Aged between 18-40 years
Target number of participants
100 individual participants
Participant exclusion criteria
Type 1 diabetic patients whose pregnancy terminated as preterm delivery
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Department of Obstetrics and Gynecology School of Medicine Zagreb
Ministry of Science, Education and Technology of the Republic of Croatia
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication of results data in a peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Josip Djelmis (firstname.lastname@example.org) and Marina Horvaticek (email@example.com). Data will be shared in agreement with another parties.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28378851