search
Back to results

Hepcidin and Glucose Metabolism

Primary Purpose

Iron Deficiency Anemia of Pregnancy, Iron Metabolism Disorders, Glucose Intolerance

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
100mg iron sulfate
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Iron Deficiency Anemia of Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Human Nutrition Laboratory ETH ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

No GDM, non-anemic

No GDM, anemic

GDM, non anemic

GDM, anemic

Arm Description

12 women with no gestational diabetes who are not anemic

12 women with no gestational diabetes who are anemic

12 women with gestational diabetes who are not anemic

12 women with gestational diabetes who are anemic

Outcomes

Primary Outcome Measures

Serum hepcidin
Serum hepcidin
Serum hepcidin
Serum hepcidin
Serum iron
Serum iron
Serum iron
Serum iron
glucose
glucose
glucose
glucose
insulin
insulin
insulin
insulin
Serum hepcidin
Serum iron
glucose
insulin

Secondary Outcome Measures

Serum ferritin
Serum ferritin
Serum ferritin
Serum ferritin
soluble transferrin receptor
soluble transferrin receptor
soluble transferrin receptor
soluble transferrin receptor
c-reactive protein
c-reactive protein
c-reactive protein
c-reactive protein
alpha glycoprotein
alpha glycoprotein
alpha glycoprotein
alpha glycoprotein

Full Information

First Posted
July 1, 2019
Last Updated
July 15, 2019
Sponsor
Swiss Federal Institute of Technology
Collaborators
University Hospital, Zürich
search

1. Study Identification

Unique Protocol Identification Number
NCT04008147
Brief Title
Hepcidin and Glucose Metabolism
Official Title
The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Women With Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
University Hospital, Zürich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia of Pregnancy, Iron Metabolism Disorders, Glucose Intolerance, Gestational Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No GDM, non-anemic
Arm Type
Active Comparator
Arm Description
12 women with no gestational diabetes who are not anemic
Arm Title
No GDM, anemic
Arm Type
Active Comparator
Arm Description
12 women with no gestational diabetes who are anemic
Arm Title
GDM, non anemic
Arm Type
Experimental
Arm Description
12 women with gestational diabetes who are not anemic
Arm Title
GDM, anemic
Arm Type
Experimental
Arm Description
12 women with gestational diabetes who are anemic
Intervention Type
Drug
Intervention Name(s)
100mg iron sulfate
Intervention Description
100mg iron sulfate b.i.d. for 4 consecutive days
Primary Outcome Measure Information:
Title
Serum hepcidin
Time Frame
before OGTT, 1 day before iron supplementation
Title
Serum hepcidin
Time Frame
after OGTT, 1 day before iron supplementation
Title
Serum hepcidin
Time Frame
before OGTT, 1 day after iron supplementation
Title
Serum hepcidin
Time Frame
after OGTT, 1 day after iron supplementation
Title
Serum iron
Time Frame
before OGTT, 1 day before iron supplementation
Title
Serum iron
Time Frame
after OGTT, 1 day before iron supplementation
Title
Serum iron
Time Frame
before OGTT, 1 day after iron supplementation
Title
Serum iron
Time Frame
after OGTT, 1 day after iron supplementation
Title
glucose
Time Frame
before OGTT, 1 day before iron supplementation
Title
glucose
Time Frame
after OGTT, 1 day before iron supplementation
Title
glucose
Time Frame
before OGTT, 1 day after iron supplementation
Title
glucose
Time Frame
after OGTT, 1 day after iron supplementation
Title
insulin
Time Frame
before OGTT, 1 day before iron supplementation
Title
insulin
Time Frame
after OGTT, 1 day before iron supplementation
Title
insulin
Time Frame
before OGTT, 1 day after iron supplementation
Title
insulin
Time Frame
after OGTT, 1 day after iron supplementation
Title
Serum hepcidin
Time Frame
7days after iron supplementation
Title
Serum iron
Time Frame
7days after iron supplementation
Title
glucose
Time Frame
7days after iron supplementation
Title
insulin
Time Frame
7days after iron supplementation
Secondary Outcome Measure Information:
Title
Serum ferritin
Time Frame
before OGTT, 1 day before iron supplementation
Title
Serum ferritin
Time Frame
after OGTT, 1 day before iron supplementation
Title
Serum ferritin
Time Frame
before OGTT, 1 day after iron supplementation
Title
Serum ferritin
Time Frame
after OGTT, 1 day after iron supplementation
Title
soluble transferrin receptor
Time Frame
before OGTT, 1 day before iron supplementation
Title
soluble transferrin receptor
Time Frame
after OGTT, 1 day before iron supplementation
Title
soluble transferrin receptor
Time Frame
before OGTT, 1 day after iron supplementation
Title
soluble transferrin receptor
Time Frame
after OGTT, 1 day after iron supplementation
Title
c-reactive protein
Time Frame
before OGTT, 1 day before iron supplementation
Title
c-reactive protein
Time Frame
after OGTT, 1 day before iron supplementation
Title
c-reactive protein
Time Frame
before OGTT, 1 day after iron supplementation
Title
c-reactive protein
Time Frame
after OGTT, 1 day after iron supplementation
Title
alpha glycoprotein
Time Frame
before OGTT, 1 day before iron supplementation
Title
alpha glycoprotein
Time Frame
after OGTT, 1 day before iron supplementation
Title
alpha glycoprotein
Time Frame
before OGTT, 1 day after iron supplementation
Title
alpha glycoprotein
Time Frame
after OGTT, 1 day after iron supplementation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnancy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole U Stoffel, PhD
Phone
+41 44 632 83 93
Email
nicole.stoffel@hest.ethz.ch
Facility Information:
Facility Name
Human Nutrition Laboratory ETH Zurich
City
Zürich
ZIP/Postal Code
8092
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole U Stoffel, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hepcidin and Glucose Metabolism

We'll reach out to this number within 24 hrs