Resistance Exercise on Postprandial Hyperglycemia in Patients With B-thalassemia Exhibiting Resistance to Insulin

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Beta-Thalassemia, Insulin Resistance, PreDiabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Resistance exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Resistance exercise 45 min following breakfast | Other: Resistance exercise<br>* 2 major muscle groups (lower extremity, chest)<br>|
| No Intervention: Control<br>No exercise (resting) following breakfast | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood glucose | Concentration of blood glucose will be measured in serum | 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 | 
| Changes in blood insulin | Concentration of blood insulin will be measured in serum | 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 | 
| Changes in blood triglycerides | Concentration of blood triglycerides will be measured in serum | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass | Body mass (kg) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany) | At the baseline and before each trial | 
| Body height | Body height (m) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany) | At the baseline | 
| Body fat | Body fat (kg and percentage) will be measured with Dual-emission X-ray absorptiometry (GE Healthcare, Lunar DPX-NT) | Before each trial | 
| Resting heart rate | Resting heart rate (beats per minute) will be monitored using Team Polar (Polar Electro Oy, Kempele, Finland) | At the baseline and before each trial | 
| Heart rate during exercise | Heart rate (beats per minute) will be monitored using continuous heart rate measurements (Team Polar, Polar Electro Oy, Kempele, Finland) | During exercise in each trial | 
| Changes in total antioxidant capacity | Concentration of total antioxidant capacity will be measured in serum | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | 
| Changes in reduced glutathione (GSH) | Concentration of GSH will be measured in erythrocyte lysate | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | 
| Changes in catalase | Concentration of catalase will be measured in erythrocyte lysate | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | 
| Changes in uric acid | Concentration of uric acid will be measured in serum | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | 
| Changes in protein carbonyls | Concentration of protein carbonyls will be measured in plasma | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise | 
| Changes in substances that react with thiobarbituric acid (TBARS) | Concentration of TBARS will be measured in plasma | Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise |