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Completed

NCT Number: NCT03889977

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance Exercise

Other

2 major muscle groups (lower extremity, chest)

Primary outcomes

  1. Changes in blood glucose

    Time frame: 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

  2. Changes in blood insulin

    Time frame: 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

  3. Changes in blood triglycerides

    Time frame: 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

Secondary outcomes

  1. Body mass

    Time frame: At the baseline and before each trial

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

  2. Body height

    Time frame: At the baseline

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

  3. Body fat

    Time frame: Before each trial

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

  4. Resting heart rate

    Time frame: At the baseline and before each trial

    Resting heart rate (beats per minute) will be monitored using Team Polar (Polar Electro Oy, Kempele, Finland)

  5. Heart rate during exercise

    Time frame: 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)

  6. Changes in total antioxidant capacity

    Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

    Concentration of total antioxidant capacity will be measured in serum

  7. Changes in reduced glutathione (GSH)

    Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

    Concentration of GSH will be measured in erythrocyte lysate

  8. Changes in catalase

    Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

    Concentration of catalase will be measured in erythrocyte lysate

  9. Changes in uric acid

    Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

    Concentration of uric acid will be measured in serum

  10. Changes in protein carbonyls

    Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

    Concentration of protein carbonyls will be measured in plasma

  11. Changes in substances that react with thiobarbituric acid (TBARS)

    Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

    Concentration of TBARS will be measured in plasma

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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