Beta-Thalassemia, Diabetes Mellitus, Type 2, Insulin Resistance, PreDiabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
2 major muscle groups (lower extremity, chest)
Sponsors
Study design
Eligibility
Inclusion criteria
* Diagnosed with Beta-Thalassemia * Diagnosed with prediabetes or type II diabetes
Exclusion criteria
* Heart failure * Hypertension * Muscular, neuromuscular, bone disorders * Muscular, bone or other injuries that do not allowed safe participation to exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood insulin | 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 |
| Changes in blood triglycerides | 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 glucose | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting heart rate | At the baseline and before each trial | Resting heart rate (beats per minute) will be monitored using Team Polar (Polar Electro Oy, Kempele, Finland) |
| Heart rate during exercise | During exercise in each trial | Heart rate (beats per minute) will be monitored using continuous heart rate measurements (Team Polar, Polar Electro Oy, Kempele, Finland) |
| Changes in total antioxidant capacity | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | Concentration of total antioxidant capacity will be measured in serum |
| Changes in reduced glutathione (GSH) | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | Concentration of GSH will be measured in erythrocyte lysate |
| Body mass | At the baseline and before each trial | Body mass (kg) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany) |
| Changes in uric acid | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | Concentration of uric acid will be measured in serum |
| Changes in protein carbonyls | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | Concentration of protein carbonyls will be measured in plasma |
| Changes in substances that react with thiobarbituric acid (TBARS) | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | Concentration of TBARS will be measured in plasma |
| Changes in catalase | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | Concentration of catalase will be measured in erythrocyte lysate |
| Body height | At the baseline | Body height (m) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany) |
| Body fat | Before each trial | Body fat (kg and percentage) will be measured with Dual-emission X-ray absorptiometry (GE Healthcare, Lunar DPX-NT) |
Countries
Greece