Hepcidin and Glucose Metabolism

Study Overview
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Brief Summary
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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.

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

Conditions
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Iron Deficiency Anemia of Pregnancy, Iron Metabolism Disorders, Glucose Intolerance, Gestational Diabetes

Intervention / Treatment
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* Dietary Supplement: 100mg iron fumarate
* Dietary Supplement: Burgerstein Schwangerschaft & Stillzeit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Iron Group<br>15 women taking 100 mg iron twice daily for 4 days (800 mg). | Dietary Supplement: 100mg iron fumarate<br>* 100mg iron fumarate b.i.d. for 4 consecutive days<br>|
| Active Comparator: Low Iron Group<br>15 women taking 30 mg iron once daily for 14 days (420 mg). | Dietary Supplement: Burgerstein Schwangerschaft & Stillzeit<br>* contains 30 mg iron fumarate, given on 14 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum hepcidin |  | before OGTT, 1 day before high/low iron supplementation | 
| Serum hepcidin |  | after OGTT, 1 day before high/low iron supplementation | 
| Serum hepcidin |  | before OGTT, after high/low iron supplementation at day 7 | 
| Serum hepcidin |  | after OGTT, after high/low iron supplementation at day 7 | 
| Serum iron |  | before OGTT, 1 day before high/low iron supplementation | 
| Serum iron |  | after OGTT, 1 day before high/low iron supplementation | 
| Serum iron |  | before OGTT, after high/low iron supplementation at day 7 | 
| Serum iron |  | after OGTT, after high/low iron supplementation at day 7 | 
| glucose |  | before OGTT, 1 day before high/low iron supplementation | 
| glucose |  | after OGTT, 1 day before high/low iron supplementation | 
| glucose |  | before OGTT, after high/low iron supplementation at day 7 | 
| glucose |  | after OGTT, after high/low iron supplementation at day 7 | 
| insulin |  | before OGTT, 1 day before high/low iron supplementation | 
| insulin |  | after OGTT, 1 day before high/low iron supplementation | 
| insulin |  | before OGTT, after high/low iron supplementation at day 7 | 
| insulin |  | after OGTT, after high/low iron supplementation at day 7 | 
| Serum hepcidin |  | At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation | 
| Serum iron |  | At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation | 
| glucose |  | At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation | 
| insulin |  | At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ferritin |  | before OGTT, 1 day before high/low iron supplementation | 
| Serum ferritin |  | after OGTT, 1 day before high/low iron supplementation | 
| Serum ferritin |  | before OGTT, after high/low iron supplementation at day 7 | 
| Serum ferritin |  | after OGTT, after high/low iron supplementation at day 7 | 
| soluble transferrin receptor |  | before OGTT, 1 day before high/low iron supplementation | 
| soluble transferrin receptor |  | after OGTT, 1 day before high/low iron supplementation | 
| soluble transferrin receptor |  | before OGTT, after high/low iron supplementation at day 7 | 
| soluble transferrin receptor |  | after OGTT, after high/low iron supplementation at day 7 | 
| c-reactive protein |  | before OGTT, 1 day before high/low iron supplementation | 
| c-reactive protein |  | after OGTT, 1 day before high/low iron supplementation | 
| c-reactive protein |  | before OGTT, after high/low iron supplementation at day 7 | 
| c-reactive protein |  | after OGTT, after high/low iron supplementation at day 7 | 
| alpha glycoprotein |  | before OGTT, 1 day before high/low iron supplementation | 
| alpha glycoprotein |  | after OGTT, 1 day before high/low iron supplementation | 
| alpha glycoprotein |  | before OGTT, after high/low iron supplementation at day 7 | 
| alpha glycoprotein |  | after OGTT, after high/low iron supplementation at day 7 |