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

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ClinicalTrials.gov Identifier: NCT03889977
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Athanasios Z. Jamurtas, University of Thessaly

Study Description
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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.

Condition or disease Intervention/treatment Phase
Beta-Thalassemia Insulin Resistance PreDiabetes Diabetes Mellitus, Type 2 Other: Resistance exercise Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Resistance Exercise on Postprandial Hyperglycemia in Patients With B-thalassemia Exhibiting Resistance to Insulin (Type II Diabetes and Prediabetes)
Actual Study Start Date : February 11, 2019
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise
Resistance exercise 45 min following breakfast
 Other: Resistance exercise
2 major muscle groups (lower extremity, chest)
No Intervention: Control
No exercise (resting) following breakfast


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889977


Locations
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Greece
Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Tríkala, Greece, 42100
Sponsors and Collaborators
University of Thessaly
Investigators
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Principal Investigator: Alexandra Stamperna, MD UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
More Information
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Responsible Party: Athanasios Z. Jamurtas, Principal Investigator, University of Thessaly
ClinicalTrials.gov Identifier: NCT03889977    
Other Study ID Numbers: B-Thalassemia ResEx Glucose
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Insulin Resistance
Diabetes Mellitus, Type 2
Hyperglycemia
Prediabetic State
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
 Endocrine System Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs