Hepcidin and Glucose Metabolism

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSwiss Federal Institute of Technology

About this trial

Gestational diabetes mellitus (GDM), defined as hyperglycemia with blood glucose values above normal but below those diagnostic of DM, and iron deficiency (ID) with or without anemia (IDA) are common during pregnancy. Both disease patterns are associated with an increased risk of complications during pregnancy and at delivery and may have a variety of negative effects on different aspects of child development. Thus, GDM and ID/IDA during pregnancy should be prevented.

Whether iron supplementation with high oral doses acutely increases hepcidin during pregnancy, and whether this acute iron-induced increase in hepcidin decreases insulin sensitivity, is uncertain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

week of pregnancy 24-28

pre-pregnancy BMI <27.5kg/m2

singleton pregnancy

Hb > 8.0 g/dl

Disqualifiers

iron infusion within the past 6 months

severely anemic Hb<8.0g/dl

acute or chronic disease

long-term medication

Trial design

Design model

Parallel

Treatments tested in this trial

  • 100mg iron fumarate

    Dietary supplement

    100mg iron fumarate b.i.d. for 4 consecutive days

  • Burgerstein Schwangerschaft & Stillzeit

    Dietary supplement

    contains 30 mg iron fumarate, given on 14 consecutive days

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: High Iron GroupActive comparator 1 intervention
Group B: Low Iron GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serum hepcidin

Time frame
before OGTT, 1 day before high/low iron supplementation
2

Serum hepcidin

Time frame
after OGTT, 1 day before high/low iron supplementation
3

Serum hepcidin

Time frame
before OGTT, after high/low iron supplementation at day 7
4

Serum hepcidin

Time frame
after OGTT, after high/low iron supplementation at day 7

Secondary outcomes

1

Serum ferritin

Time frame
before OGTT, 1 day before high/low iron supplementation
2

Serum ferritin

Time frame
after OGTT, 1 day before high/low iron supplementation
3

Serum ferritin

Time frame
before OGTT, after high/low iron supplementation at day 7
4

Serum ferritin

Time frame
after OGTT, after high/low iron supplementation at day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Swiss Federal Institute of Technology

Lead sponsor

University Hospital, Zürich

Collaborator