Effects of a Standard Blood Bank Donation on Insulin Sensitivity in Adults with Pre-diabetes and Abdominal Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Insulin sensitivity during an oral glucose tolerance test (OGTT)
研究概览
简要总结
Studies in the literature suggest that people with obesity have an excess of stored iron. There is possibly an inverse relationship between ferritin levels and the actions of insulin on glycemic control. The reduction of stored iron by simply donating blood could result in improvements in glycemic control in people with obesity and prediabetes. We propose, to reduce ferritin levels through a standard donation of a unit of whole blood, and to measure if it positively affects glycemic control.
详细描述
Individuals with pre-diabetes and abdominal obesity will be randomized to either a donation group (DON) or a control group (CONT) in a double-blind fashion (RCT).
Insulin sensitivity during an oral glucose tolerance test (OGTT) and isotopically measured rate of appearance of endogenous and exogenous glucose will be measured on 2 occasions.
- Two weeks prior to DON/CONT
- Two weeks after to DON/CONT
Indexes of the bodily iron stores will be measured after DON/CONT to evaluate if the primary treatment was effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
participants in the control group will have the standard blood bank donation venipuncture, but no blood will be withdrawn (sham donation).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have not donated in the last 3 months
- •fasting blood glucose 100-125 mg/dL
- •glycosylated hemoglobin levels between 5.7-6.4%
排除标准
- •to not meet donor bank requirements
- •insulin treatment for diabetes
- •hereditary hemochromatosis
- •heart disease
- •familial hypertriglyceridemia or hypobetalipoproteinemia
- •any disease that requires medication that interferes with iron or glucose metabolism
结局指标
主要结局
Insulin sensitivity during an oral glucose tolerance test (OGTT)
时间窗: 7 months
Measured with the calculations of Matsuda index
Turnover rate of endogenous and exogenous glucose
时间窗: 7 months
Measured using isotopic tracers.
Carbohydrate oxidation
时间窗: 7 months
Measured using indirect calorimetry
Ferritin blood level
时间窗: 7 months
iron stores index measured in blood
Continuous glucose monitoring
时间窗: 7 months
Interstitial blood glucose concentrations during 24-h
次要结局
- Body composition (weight and body fat)(7 months)
- Cuality of life(7 months)
- Fasting lipid profile(7 months)
研究者
Ricardo Mora
Director of Exercise Physiology Laboratory
University of Castilla-La Mancha