Gestational Diabetes Clinical Trial
Official title:
The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Pregnancy
NCT number | NCT04008147 |
Other study ID # | INDIA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 3, 2019 |
Est. completion date | December 31, 2023 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Human Nutrition Laboratory ETH Zurich | Zürich |
Lead Sponsor | Collaborator |
---|---|
Swiss Federal Institute of Technology | University Hospital, Zürich |
Switzerland,
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 |
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