Hepcidin and Glucose Metabolism

Sponsor
Swiss Federal Institute of Technology
Study ID
NCT04008147
Status
Recruiting
Apply to this trial

Conditions

  • Gestational Diabetes
  • Glucose Intolerance
  • Iron Deficiency Anemia of Pregnancy
  • Iron Metabolism Disorders

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Jul 5, 2019
Start date
Jul 3, 2019
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: High Iron Group
    15 women taking 100 mg iron twice daily for 4 days (800 mg).
  • Active Comparator: Low Iron Group
    15 women taking 30 mg iron once daily for 14 days (420 mg).

Primary Outcome Measure

Serum hepcidin [ Time Frame: before OGTT, 1 day before high/low iron supplementation ]

Central Contacts

Related Studies