Preservation of insulin C-peptide in pregnant women with type 1 diabetes mellitus

• Register: ISRCTN
• Last refreshed on: 23 October 2023
• Main ID: ISRCTN15203878
• Date of registration: 15/09/2016
• Prospective Registration: No
• Primary sponsor: University of Zagreb, School of Medicine
• Public title: Preservation of insulin C-peptide in pregnant women with type 1 diabetes mellitus
• Scientific title: The impact of EPA and DHA supplementation on C-peptide preservation in type 1 diabetic pregnant women
• Date of first enrolment: 19/12/2013
• Target sample size: 150
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN15203878
• Study type: Interventional
• Study design: Randomized controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Croatia

Contacts

• Name: Josip Djelmis

Key inclusion & exclusion criteria

Inclusion criteria:
1. Pregnant women
2. Diagnosis of type 1 diabetes
3. Provision of informed consent
4. Aged between 18-40 years

Exclusion criteria: Type 1 diabetic patients whose pregnancy terminated as preterm delivery

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Type 1 diabetes mellitus in pregnant women
Nutritional, Metabolic, Endocrine
Type 1 diabetes mellitus

Intervention(s)

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(s)

FC-peptide concentration is measured by the electrochemiluminescence immunoassay “ECLIA” at baseline, 20 weeks gestation, 30 weeks gestation and at delivery.

Secondary Outcome(s)

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

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Ministry of Science, Education and Technology of the Republic of Croatia

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Ethics Committee School of Medicine University of Zagreb, 12/12/2013, ref: 021-1/206 A-13

Results

• Results available: Yes
• Date Completed: 31/12/2021