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出境医 / 临床实验 / Hepcidin and Glucose Metabolism
Hepcidin and Glucose Metabolism
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 | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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 : | July 3, 2019 |
| Estimated Primary Completion Date : | November 30, 2019 |
| Estimated Study Completion Date : | November 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 [ Time Frame: before OGTT, 1 day before iron supplementation ]
- Serum hepcidin [ Time Frame: after OGTT, 1 day before iron supplementation ]
- Serum hepcidin [ Time Frame: before OGTT, 1 day after iron supplementation ]
- Serum hepcidin [ Time Frame: after OGTT, 1 day after iron supplementation ]
- Serum iron [ Time Frame: before OGTT, 1 day before iron supplementation ]
- Serum iron [ Time Frame: after OGTT, 1 day before iron supplementation ]
- Serum iron [ Time Frame: before OGTT, 1 day after iron supplementation ]
- Serum iron [ Time Frame: after OGTT, 1 day after iron supplementation ]
- glucose [ Time Frame: before OGTT, 1 day before iron supplementation ]
- glucose [ Time Frame: after OGTT, 1 day before iron supplementation ]
- glucose [ Time Frame: before OGTT, 1 day after iron supplementation ]
- glucose [ Time Frame: after OGTT, 1 day after iron supplementation ]
- insulin [ Time Frame: before OGTT, 1 day before iron supplementation ]
- insulin [ Time Frame: after OGTT, 1 day before iron supplementation ]
- insulin [ Time Frame: before OGTT, 1 day after iron supplementation ]
- insulin [ Time Frame: after OGTT, 1 day after iron supplementation ]
- Serum hepcidin [ Time Frame: 7days after iron supplementation ]
- Serum iron [ Time Frame: 7days after iron supplementation ]
- glucose [ Time Frame: 7days after iron supplementation ]
- insulin [ Time Frame: 7days after iron supplementation ]
Secondary Outcome Measures :
- Serum ferritin [ Time Frame: before OGTT, 1 day before iron supplementation ]
- Serum ferritin [ Time Frame: after OGTT, 1 day before iron supplementation ]
- Serum ferritin [ Time Frame: before OGTT, 1 day after iron supplementation ]
- Serum ferritin [ Time Frame: after OGTT, 1 day after iron supplementation ]
- soluble transferrin receptor [ Time Frame: before OGTT, 1 day before iron supplementation ]
- soluble transferrin receptor [ Time Frame: after OGTT, 1 day before iron supplementation ]
- soluble transferrin receptor [ Time Frame: before OGTT, 1 day after iron supplementation ]
- soluble transferrin receptor [ Time Frame: after OGTT, 1 day after iron supplementation ]
- c-reactive protein [ Time Frame: before OGTT, 1 day before iron supplementation ]
- c-reactive protein [ Time Frame: after OGTT, 1 day before iron supplementation ]
- c-reactive protein [ Time Frame: before OGTT, 1 day after iron supplementation ]
- c-reactive protein [ Time Frame: after OGTT, 1 day after iron supplementation ]
- alpha glycoprotein [ Time Frame: before OGTT, 1 day before iron supplementation ]
- alpha glycoprotein [ Time Frame: after OGTT, 1 day before iron supplementation ]
- alpha glycoprotein [ Time Frame: before OGTT, 1 day after iron supplementation ]
- alpha glycoprotein [ Time Frame: after OGTT, 1 day after iron supplementation ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | pregnancy |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Nicole U Stoffel, PhD | +41 44 632 83 93 | nicole.stoffel@hest.ethz.ch |
Locations
| Switzerland | |
| Human Nutrition Laboratory ETH Zurich | Recruiting |
| Zürich, Switzerland, 8092 | |
| Contact: Nicole U Stoffel, PhD | |
Sponsors and Collaborators
Swiss Federal Institute of Technology
University Hospital, Zürich
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 1, 2019 | ||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||
| Last Update Posted Date | July 16, 2019 | ||||||
| Actual Study Start Date ICMJE | July 3, 2019 | ||||||
| Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Hepcidin and Glucose Metabolism | ||||||
| Official Title ICMJE | The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Women With Gestational Diabetes | ||||||
| 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. |
||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE |
|
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| Intervention ICMJE | Drug: 100mg iron sulfate
100mg iron sulfate b.i.d. for 4 consecutive days
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
48 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | November 30, 2019 | ||||||
| Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
With either:
OR:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 45 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Switzerland | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04008147 | ||||||
| Other Study ID Numbers ICMJE | INDIA | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Nicole Stoffel, Swiss Federal Institute of Technology | ||||||
| Study Sponsor ICMJE | Swiss Federal Institute of Technology | ||||||
| Collaborators ICMJE | University Hospital, Zürich | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Swiss Federal Institute of Technology | ||||||
| Verification Date | July 2019 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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