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The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women

ConditionOverweight and Obese Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorNicole Stoffel

About this trial

The study will be a randomized, double-blind, 17-day metabolic intervention trial including 14 days of high-dose or low-dose iron supplementation. A total of 70 overweight or obese (OW/OB) women will be enrolled. Participants will be individually randomized into either the high-iron or low-iron group.

Women in the low-iron group will receive 15 mg of iron as ferrous fumarate daily for 14 days, while women in the high-iron group will receive 195 mg of iron as ferrous sulfate daily for 14 days.

The study consists of three visits in total. On Day 0, a fasting blood sample will be collected and an OGTT will be performed, with additional blood samples collected at 1 hour and 2 hours post-OGTT. The OGTT will be repeated on Day 14, after 14 days of oral iron supplementation, and again on Day 17, four days after oral iron supplementation has been stopped

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI ≥ 27.5 kg/m2

serum ferritin <30 μg/L

hemoglobin ≥ 11 g/dl

fasting blood glucose < 5.6 mmol/L

Disqualifiers

intravenous or high dose oral iron in the preceding 2 months

medical disorders are known to affect iron absorption or metabolism, or T2DM

cigarette smoking

recent blood transfusion or major blood loss

Trial design

Design model

Parallel

Treatments tested in this trial

  • 195 mg iron daily

    Dietary supplement

    3 x 65 mg iron as ferrous sulfate

  • 15 mg iron daily

    Dietary supplement

    3 x 5 mg iron as ferrous sulfate

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: high-dose iron supplementationExperimental treatment 1 intervention
Group B: low-dose iron supplementationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood glucose increase during OGTT Day 0

Blood glucose increase during OGTT before the intake of oral iron for 14 days

Time frame
Day 0
2

Blood glucose increase during OGTT Day 14

Blood glucose increase during OGTT after the intake of oral iron for 14 days

Time frame
Day 14

Secondary outcomes

1

Insulin increase during OGTT Day 0

Insulin increase during OGTT before the intake of oral iron for 14 days

Time frame
Day 0
2

Insulin increase during OGTT Day 14

Insulin increase during OGTT after the intake of oral iron for 14 days

Time frame
Day 14
3

Serum Hepcidin Day 0

Serum Hepcidin measured before the intake of oral iron

Time frame
Day 0
4

Serum Hepcidin D14

Serum Hepcidin measured after the intake of oral iron

Time frame
Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicole Stoffel

Lead sponsor

ETH Zurich

Sponsor institution

American University of Beirut Medical Center

Collaborator

Source ClinicalTrials.gov
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