Hepcidin and Glucose Metabolism

Gestational Diabetes Clinical Trial

Official title:

The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04008147
• Other study ID #: INDIA
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Swiss Federal Institute of Technology
• Contact: Nicole U Stoffel, PhD
• Phone: +41 44 632 83 93
• Email: nicole.stoffel[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• week of pregnancy 24-28

• pre-pregnancy BMI <27.5kg/m2

• singleton pregnancy

• Hb > 8.0 g/dl

Willing to either:

• not take any iron supplements for 14 days (however, participants will receive a similar amount of total iron during the 4 study days that they would normally receive over 14 days) OR

• to take the multivitamin "Burgerstein Schwangerschaft and Stillzeit" supplements over the 14 days (contains 30 mg iron)

Exclusion Criteria:

• iron infusion within the past 6 months

• severely anemic Hb<8.0g/dl

• acute or chronic disease

• long-term medication

• medical problems known to affect iron homeostasis

• smoking

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Diabetes, Gestational
• Gestational Diabetes
• Glucose Intolerance
• Iron Deficiency Anemia of Pregnancy
• Iron Metabolism Disorders
• Metabolic Diseases

Intervention

Dietary Supplement:
• 100mg iron fumarate
100mg iron fumarate b.i.d. for 4 consecutive days
• Burgerstein Schwangerschaft & Stillzeit
contains 30 mg iron fumarate, given on 14 consecutive days

Locations

Country	Name	City	State
Switzerland	Human Nutrition Laboratory ETH Zurich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum hepcidin		before OGTT, 1 day before high/low iron supplementation
Primary	Serum hepcidin		after OGTT, 1 day before high/low iron supplementation
Primary	Serum hepcidin		before OGTT, after high/low iron supplementation at day 7
Primary	Serum hepcidin		after OGTT, after high/low iron supplementation at day 7
Primary	Serum iron		before OGTT, 1 day before high/low iron supplementation
Primary	Serum iron		after OGTT, 1 day before high/low iron supplementation
Primary	Serum iron		before OGTT, after high/low iron supplementation at day 7
Primary	Serum iron		after OGTT, after high/low iron supplementation at day 7
Primary	glucose		before OGTT, 1 day before high/low iron supplementation
Primary	glucose		after OGTT, 1 day before high/low iron supplementation
Primary	glucose		before OGTT, after high/low iron supplementation at day 7
Primary	glucose		after OGTT, after high/low iron supplementation at day 7
Primary	insulin		before OGTT, 1 day before high/low iron supplementation
Primary	insulin		after OGTT, 1 day before high/low iron supplementation
Primary	insulin		before OGTT, after high/low iron supplementation at day 7
Primary	insulin		after OGTT, after high/low iron supplementation at day 7
Primary	Serum hepcidin		At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Primary	Serum iron		At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Primary	glucose		At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Primary	insulin		At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Secondary	Serum ferritin		before OGTT, 1 day before high/low iron supplementation
Secondary	Serum ferritin		after OGTT, 1 day before high/low iron supplementation
Secondary	Serum ferritin		before OGTT, after high/low iron supplementation at day 7
Secondary	Serum ferritin		after OGTT, after high/low iron supplementation at day 7
Secondary	soluble transferrin receptor		before OGTT, 1 day before high/low iron supplementation
Secondary	soluble transferrin receptor		after OGTT, 1 day before high/low iron supplementation
Secondary	soluble transferrin receptor		before OGTT, after high/low iron supplementation at day 7
Secondary	soluble transferrin receptor		after OGTT, after high/low iron supplementation at day 7
Secondary	c-reactive protein		before OGTT, 1 day before high/low iron supplementation
Secondary	c-reactive protein		after OGTT, 1 day before high/low iron supplementation
Secondary	c-reactive protein		before OGTT, after high/low iron supplementation at day 7
Secondary	c-reactive protein		after OGTT, after high/low iron supplementation at day 7
Secondary	alpha glycoprotein		before OGTT, 1 day before high/low iron supplementation
Secondary	alpha glycoprotein		after OGTT, 1 day before high/low iron supplementation
Secondary	alpha glycoprotein		before OGTT, after high/low iron supplementation at day 7
Secondary	alpha glycoprotein		after OGTT, after high/low iron supplementation at day 7