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

The impact of EPA and DHA supplementation on C-peptide preservation in type 1 diabetic pregnant women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15203878

Enrollment

150

Registered

2016-09-15

Start date

2013-12-19

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Participants are randomly allocated to one of two groups: Intervention group: Participants take capsules containing 60mg EPA (eicosapentanoic) and 308 mg DHA (docosahexanoic acid) twic

Eligibility

Sex/Gender

Female

Inclusion 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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Croatia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026