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

Nicole Stoffel70 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Overweight and Obese Women

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI ≥ 27.5 kg/m2 * serum ferritin \<30 μg/L * hemoglobin ≥ 11 g/dl * fasting blood glucose \< 5.6 mmol/L Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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

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

Insulin increase during OGTT Day 0

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

Time frame: Day 0

Insulin increase during OGTT Day 14

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

Time frame: Day 14

Serum Hepcidin Day 0

Serum Hepcidin measured before the intake of oral iron

Time frame: Day 0

Serum Hepcidin D14

Serum Hepcidin measured after the intake of oral iron

Time frame: Day 14

Serum Ferritin Day 0

Serum Ferritin measured before the intake of oral iron

Time frame: Day 0

Serum Ferritin Day 14

Serum Ferritin measured after the intake of oral iron

Time frame: Day 14

Soluble Transferrin Receptor (sTfR) Day 0

sTfR measured before the intake of oral iron

Time frame: Day 0

Soluble Transferrin Receptor (sTfR) Day 14

sTfR measured after the intake of oral iron

Time frame: Day 14

Hemoglobin Day 0

Hemoglobin measured before the intake of oral iron

Time frame: Day 0

Hemoglobin Day 14

Hemoglobin measured after the intake of oral iron

Time frame: Day 14

C-reactive protein (CRP) Day 0

CRP measured before the intake of oral iron

Time frame: Day 0

C-reactive protein (CRP) Day 14

CRP measured after the intake of oral iron

Time frame: Day 14

Alpha-1-acid glycoprotein (AGP) Day 0

AGP measured before the intake of oral iron

Time frame: Day 0

Alpha-1-acid glycoprotein (AGP) Day 14

AGP measured after the intake of oral iron

Time frame: Day 14

Serum Iron Day 0

Serum Iron measured before the intake of oral iron

Time frame: Day 0

Serum Iron Day 14

Serum Iron measured after the intake of oral iron

Time frame: Day 14

Total Iron Binding Capacity (TIBC) Day 0

TIBC measured before the intake of oral iron

Time frame: Day 0

Total Iron Binding Capacity (TIBC) Day 14

TIBC measured after the intake of oral iron

Time frame: Day 14

Transferrin Saturation (TSAT) Day 0

TSAT measured before the intake of oral iron

Time frame: Day 0

Transferrin Saturation (TSAT) Day 14

TSAT measured after the intake of oral iron

Time frame: Day 14

Transferrin Saturation (TSAT) Day 17

TSAT measured at endpoint

Time frame: Day 17

Total Iron Binding Capacity (TIBC) Day 17

TIBC measured at endpoint

Time frame: Day 17

Serum Iron Day 17

Serum Iron measured at endpoint

Time frame: Day 17

Serum Hepcidin Day 17

Serum Hepcidin measured at endpoint

Time frame: Day 17

Insulin increase during OGTT Day 17

Insulin increase during OGTT at Endpoint

Time frame: Day 17

Blood glucose increase during OGTT Day 17

Blood glucose increase during OGTT at Endpoint

Time frame: Day 17

Fasting blood glucose Day 0

Fasting blood glucose before iron intake

Time frame: Day 0

Fasting blood glucose Day 14

Fasting blood glucose after iron intake

Time frame: Day 14

Fasting blood glucose Day 17

Fasting blood glucose at Endpoint

Time frame: Day 17

Fasting insulin Day 0

Fasting insulin before iron intake

Time frame: Day 0

Fasting insulin Day 14

Fasting insulin after iron intake

Time frame: Day 14

Fasting insulin Day 17

Fasting insulin at Endpoint

Time frame: Day 17

Blood glucose profile measured over the 14 days

blood glucose profile measured by wearable FreeStyle Libre Sensor

Time frame: Day 0 - Day 14

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts