The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Blood glucose increase during OGTT Day 0
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 27.5 kg/m2
- •serum ferritin <30 μg/L
- •hemoglobin ≥ 11 g/dl
- •fasting blood glucose < 5.6 mmol/L
排除标准
- •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
结局指标
主要结局
Blood glucose increase during OGTT Day 0
时间窗: Day 0
Blood glucose increase during OGTT before the intake of oral iron for 14 days
Blood glucose increase during OGTT Day 14
时间窗: Day 14
Blood glucose increase during OGTT after the intake of oral iron for 14 days
次要结局
- Insulin increase during OGTT Day 0(Day 0)
- Insulin increase during OGTT Day 14(Day 14)
- Serum Hepcidin Day 0(Day 0)
- Serum Hepcidin D14(Day 14)
- Serum Ferritin Day 0(Day 0)
- Serum Ferritin Day 14(Day 14)
- Soluble Transferrin Receptor (sTfR) Day 0(Day 0)
- Soluble Transferrin Receptor (sTfR) Day 14(Day 14)
- Hemoglobin Day 0(Day 0)
- Hemoglobin Day 14(Day 14)
- C-reactive protein (CRP) Day 0(Day 0)
- C-reactive protein (CRP) Day 14(Day 14)
- Alpha-1-acid glycoprotein (AGP) Day 0(Day 0)
- Alpha-1-acid glycoprotein (AGP) Day 14(Day 14)
- Serum Iron Day 0(Day 0)
- Transferrin Saturation (TSAT) Day 0(Day 0)
- Serum Iron Day 14(Day 14)
- Total Iron Binding Capacity (TIBC) Day 0(Day 0)
- Total Iron Binding Capacity (TIBC) Day 14(Day 14)
- Transferrin Saturation (TSAT) Day 14(Day 14)
- Transferrin Saturation (TSAT) Day 17(Day 17)
- Total Iron Binding Capacity (TIBC) Day 17(Day 17)
- Serum Iron Day 17(Day 17)
- Serum Hepcidin Day 17(Day 17)
- Insulin increase during OGTT Day 17(Day 17)
- Blood glucose increase during OGTT Day 17(Day 17)
- Fasting blood glucose Day 0(Day 0)
- Fasting blood glucose Day 14(Day 14)
- Fasting blood glucose Day 17(Day 17)
- Fasting insulin Day 0(Day 0)
- Fasting insulin Day 14(Day 14)
- Fasting insulin Day 17(Day 17)
- Blood glucose profile measured over the 14 days(Day 0 - Day 14)
研究者
Nicole Stoffel
Prof. Dr.
ETH Zurich