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

Not Applicable
Completed
Conditions
Beta-Thalassemia
PreDiabetes
Insulin Resistance
Diabetes Mellitus, Type 2
Interventions
Other: Resistance exercise
Registration Number
NCT03889977
Lead Sponsor
University of Thessaly
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
ExerciseResistance exerciseResistance exercise 45 min following breakfast
Primary Outcome Measures
NameTimeMethod
Changes in blood glucosePre-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 triglyceridesPre-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 insulinPre-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

Secondary Outcome Measures
NameTimeMethod
Changes in catalasePre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

Concentration of catalase will be measured in erythrocyte lysate

Changes in uric acidPre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

Concentration of uric acid will be measured in serum

Body heightAt the baseline

Body height (m) will be measured with Beam Balance-Stadiometer (SECA, Vogel \& Halke, Hamburg, Germany)

Resting heart rateAt 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 exerciseDuring 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 reduced glutathione (GSH)Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

Concentration of GSH will be measured in erythrocyte lysate

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 total antioxidant capacityPre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

Concentration of total antioxidant capacity will be measured in serum

Body massAt the baseline and before each trial

Body mass (kg) will be measured with Beam Balance-Stadiometer (SECA, Vogel \& Halke, Hamburg, Germany)

Body fatBefore each trial

Body fat (kg and percentage) will be measured with Dual-emission X-ray absorptiometry (GE Healthcare, Lunar DPX-NT)

Changes in protein carbonylsPre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

Concentration of protein carbonyls will be measured in plasma

Trial Locations

Locations (1)

Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

🇬🇷

Tríkala, Greece

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