Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/09/2016
Date assigned
15/09/2016
Last edited
15/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 2016

Who is funding the study?
Ministry of Science, Education and Technology of the Republic of Croatia (Croatia)

Who is the main contact?
Professor 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 1 4578330
josip.djelmis@zg.t-com.hr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ClinicalTrials.gov

Study information

Scientific title

The impact of EPA and DHA suplementation 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) on secretion fasting C-peptide in pregnant women with type-1 diabetes.

Ethics approval

Ethics Commitee 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 below to request a patient information sheet

Condition

Type 1 diabetes mellitus

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 placebotwice 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 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

01/12/2013

Overall trial end date

30/09/2016

Reason abandoned

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

100 individual participants

Participant exclusion criteria

Type 1 diabetic patients whose pregnancy terminated as preterm delivery.

Recruitment start date

19/12/2013

Recruitment end date

30/05/2016

Locations

Countries of recruitment

Croatia

Trial participating centre

Department of Obstetrics and Gynecology School of Medicine Zagreb
Petrova 13
Zagreb
10000
Croatia

Sponsor information

Organisation

University of Zagreb, School of Medicine

Sponsor details

Salata 3
Zagreb
1000
Croatia

Sponsor type

University/education

Website

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.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes