跳至主要内容
临床试验/NCT03889977
NCT03889977已完成不适用

The Effect of Resistance Exercise on Postprandial Hyperglycemia in Patients With B-thalassemia Exhibiting Resistance to Insulin (Type II Diabetes and Prediabetes)

University of Thessaly2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2019年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Changes in blood glucose

研究概览

简要总结

It is known that postprandial hyperglycemia increases the cardiometabolic risk in both diabetic and non-diabetic patients. Moreover, there is insufficient data on the effectiveness of exercise on preventing Type II diabetes mellitus in individuals with insulin resistance and prediabetes. This study aims to examine the effectiveness of resistance exercise in limiting postprandial hyperglycemia and the necessity of prescribing medication particularly in patients with beta-thalassemia and insulin resistance.

详细描述

Type II diabetes mellitus is a condition characterized by chronic hyperglycemia due to insufficient insulin production and action and tissue resistance to insulin. Pre-diabetes is also characterized by elevated levels of blood glucose, but not so high as those in diabetes.

Existing studies have shown that postprandial hyperglycemia is associated with an increased risk for complications of diabetes, both microvascular and macrovascular, as it contributes to the deficiency of β-pancreatic cells and endothelial dysfunction to a much greater extent than glycosylated hemoglobin (HbA1c) and fasting glucose.

The main problem in glycemic control is the glucose peak 1-2 hours after the meal. Therefore, there is a need to investigate whether postprandial exercise can help solve this problem.

Βeta-thalassemia is a group of heterogeneous hereditary anemias characterized by decreased or no production of beta-chain hemoglobin, resulting in inefficient erythropoiesis. The three main phenotypes are: a) major b) intermediate and c) heterozygous beta-thalassemia. Major thalassemia occurs in the first 2 years of life with severe anemia and requires systemic transfusions. The intermediate appears later and usually does not need transfusions. The heterozygote is asymptomatic, but some carriers may experience mild anemia. Beta-thalassemia is inherited in an autosomal recessive manner. Patient survival has increased significantly in recent years due to systemic transfusions and early treatment of disease complications. However, multiple transfusions result in the accumulation of large quantities of iron, which is toxic to pancreatic beta cells. Both decreased insulin production and decreased tissue sensitivity to insulin occur and result in pre-diabetes or Type II diabetes.

Regarding the effect of exercise on diabetic patients, it is confirmed that it reduces both the blood glucose concentration and hyperglycemia during the day. Resistance exercise increases heat production and oxygen consumption by the muscles, thus increasing metabolic activity and glucose uptake by these muscles. In addition, resistance exercise improves glycemic control without causing hypoglycemia and without affecting fasting glucose. Thus, the aim of this study is examine the effectiveness of resistance exercise in limiting postprandial hyperglycemia in patients with beta-thalassemia and insulin resistance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Beta-Thalassemia
  • Diagnosed with prediabetes or type II diabetes

排除标准

  • Heart failure
  • Hypertension
  • Muscular, neuromuscular, bone disorders
  • Muscular, bone or other injuries that do not allowed safe participation to exercise

结局指标

主要结局

Changes in blood glucose

时间窗: Pre-breakfast (fasting glucose), 45 min post-breakfast (before exercise), immediately post-exercise, 1 hour post-exercise, 2 hours post-exercise, 24 hours post-exercise

Concentration of blood glucose will be measured in serum

Changes in blood triglycerides

时间窗: Pre-breakfast (fasting glucose), 45 min post-breakfast (before exercise), immediately post-exercise, 1 hour post-exercise, 2 hours post-exercise, 24 hours post-exercise

Concentration of blood triglycerides will be measured in serum

Changes in blood insulin

时间窗: Pre-breakfast (fasting glucose), 45 min post-breakfast (before exercise), immediately post-exercise, 1 hour post-exercise, 2 hours post-exercise, 24 hours post-exercise

Concentration of blood insulin will be measured in serum

次要结局

  • Changes in catalase(Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise)
  • Changes in uric acid(Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise)
  • Body height(At the baseline)
  • Resting heart rate(At the baseline and before each trial)
  • Heart rate during exercise(During exercise in each trial)
  • Changes in reduced glutathione (GSH)(Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise)
  • Changes in substances that react with thiobarbituric acid (TBARS)(Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise)
  • Changes in total antioxidant capacity(Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise)
  • Body mass(At the baseline and before each trial)
  • Body fat(Before each trial)
  • Changes in protein carbonyls(Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Athanasios Z. Jamurtas

Principal Investigator

University of Thessaly

研究点 (2)

Loading locations...

相似试验