Hepcidin and Glucose Metabolism

Sponsor

Swiss Federal Institute of Technology (Other)

Overall Status

Unknown status

CT.gov ID

NCT04008147

Collaborator

University Hospital, Zürich (Other)

Enrollment

Location

Arms

4.9

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia of Pregnancy Iron Metabolism Disorders Glucose Intolerance Gestational Diabetes	Drug: 100mg iron sulfate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Women With Gestational Diabetes

Actual Study Start Date :

Jul 3, 2019

Anticipated Primary Completion Date :

Nov 30, 2019

Anticipated Study Completion Date :

Nov 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: No GDM, non-anemic 12 women with no gestational diabetes who are not anemic	Drug: 100mg iron sulfate 100mg iron sulfate b.i.d. for 4 consecutive days
Active Comparator: No GDM, anemic 12 women with no gestational diabetes who are anemic	Drug: 100mg iron sulfate 100mg iron sulfate b.i.d. for 4 consecutive days
Experimental: GDM, non anemic 12 women with gestational diabetes who are not anemic	Drug: 100mg iron sulfate 100mg iron sulfate b.i.d. for 4 consecutive days
Experimental: GDM, anemic 12 women with gestational diabetes who are anemic	Drug: 100mg iron sulfate 100mg iron sulfate b.i.d. for 4 consecutive days

Outcome Measures

Primary Outcome Measures

Serum hepcidin [before OGTT, 1 day before iron supplementation]
Serum hepcidin [after OGTT, 1 day before iron supplementation]
Serum hepcidin [before OGTT, 1 day after iron supplementation]
Serum hepcidin [after OGTT, 1 day after iron supplementation]
Serum iron [before OGTT, 1 day before iron supplementation]
Serum iron [after OGTT, 1 day before iron supplementation]
Serum iron [before OGTT, 1 day after iron supplementation]
Serum iron [after OGTT, 1 day after iron supplementation]
glucose [before OGTT, 1 day before iron supplementation]
glucose [after OGTT, 1 day before iron supplementation]
glucose [before OGTT, 1 day after iron supplementation]
glucose [after OGTT, 1 day after iron supplementation]
insulin [before OGTT, 1 day before iron supplementation]
insulin [after OGTT, 1 day before iron supplementation]
insulin [before OGTT, 1 day after iron supplementation]
insulin [after OGTT, 1 day after iron supplementation]
Serum hepcidin [7days after iron supplementation]
Serum iron [7days after iron supplementation]
glucose [7days after iron supplementation]
insulin [7days after iron supplementation]

Secondary Outcome Measures

Serum ferritin [before OGTT, 1 day before iron supplementation]
Serum ferritin [after OGTT, 1 day before iron supplementation]
Serum ferritin [before OGTT, 1 day after iron supplementation]
Serum ferritin [after OGTT, 1 day after iron supplementation]
soluble transferrin receptor [before OGTT, 1 day before iron supplementation]
soluble transferrin receptor [after OGTT, 1 day before iron supplementation]
soluble transferrin receptor [before OGTT, 1 day after iron supplementation]
soluble transferrin receptor [after OGTT, 1 day after iron supplementation]
c-reactive protein [before OGTT, 1 day before iron supplementation]
c-reactive protein [after OGTT, 1 day before iron supplementation]
c-reactive protein [before OGTT, 1 day after iron supplementation]
c-reactive protein [after OGTT, 1 day after iron supplementation]
alpha glycoprotein [before OGTT, 1 day before iron supplementation]
alpha glycoprotein [after OGTT, 1 day before iron supplementation]
alpha glycoprotein [before OGTT, 1 day after iron supplementation]
alpha glycoprotein [after OGTT, 1 day after iron supplementation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

week of pregnancy 24-28
pre-pregnancy BMI <27.5kg/m2
singleton pregnancy

With either:

GDM and anemia
GDM and no anemia

OR:

No GDM and anemia
No GDM and no anemia

Exclusion Criteria:

iron infusion within the past 6 months
severely anemic Hb<8.0g/dl
acute or chronic disease
long-term medication
smoking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Human Nutrition Laboratory ETH Zurich	Zürich		Switzerland	8092

Sponsors and Collaborators

Swiss Federal Institute of Technology
University Hospital, Zürich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nicole Stoffel, PhD, Swiss Federal Institute of Technology

ClinicalTrials.gov Identifier:

NCT04008147

Other Study ID Numbers:

INDIA

First Posted:

Jul 5, 2019

Last Update Posted:

Jul 16, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes, Gestational

Anemia, Iron-Deficiency

Metabolic Diseases

Glucose Intolerance

Iron Metabolism Disorders

Study Results

No Results Posted as of Jul 16, 2019