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 beta 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 9 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
josip.djelmis@zg.t-com.hr
Trial website
Contact information
Type
Scientific
Primary contact
Prof Josip Djelmis
ORCID ID
http://orcid.org/0000-0002-7332-5936
Contact details
Deparment of Obstetrics and Gynecology
School of Medicine
University of Zagreb
Petrova 13
Zagreb
1000
Croatia
+385 (0)1 4578330
josip.djelmis@zg.t-com.hr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The impact of EPA and DHA supplementation on C-peptide preservation in type 1 diabetic pregnant women
Acronym
Study hypothesis
The aim of this study is to find the impact of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA) supplementation on secretion of fasting C-peptide in pregnant women with type 1 diabetes.
Ethics approval
Ethics Committee School of Medicine University of Zagreb, 12/12/2013, ref: 021-1/206 A-13
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Type 1 diabetes mellitus in pregnant women
Intervention
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.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
FC-peptide concentration is measured by the electrochemiluminescence immunoassay “ECLIA” at baseline, 20 weeks gestation, 30 weeks gestation and at delivery.
Secondary outcome measures
Current secondary outcome measures as of 10/09/2020:
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
4. Total lipid profile measured from blood samples (serum) taken at baseline, 2nd and 3rd trimester and at delivery (from mothers and from umbilical cord)
_____
Previous 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
01/12/2013
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pregnant women
2. Diagnosis of type 1 diabetes
3. Provision of informed consent
4. Aged between 18-40 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
150 individual participants
Participant exclusion criteria
Type 1 diabetic patients whose pregnancy terminated as preterm delivery
Recruitment start date
19/12/2013
Recruitment end date
30/05/2021
Locations
Countries of recruitment
Croatia
Trial participating centre
Department of Obstetrics and Gynecology School of Medicine Zagreb
Petrova 13
Zagreb
10000
Croatia
Funders
Funder type
Government
Funder name
Ministry of Science, Education and Technology of the Republic of Croatia
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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 (josip.djelmis@zg.t-com.hr) and Marina Horvaticek (marina.horvaticek@gmail.com). Data will be shared in agreement with another parties.
Intention to publish date
30/06/2022
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28378851