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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

Tracking Information
First Submitted Date  ICMJE March 22, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE February 11, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
  • 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)
  • Body height [ Time Frame: At the baseline ]
    Body height (m) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resistance Exercise on Postprandial Hyperglycemia in Patients With B-thalassemia Exhibiting Resistance to Insulin
Official Title  ICMJE The Effect of Resistance Exercise on Postprandial Hyperglycemia in Patients With B-thalassemia Exhibiting Resistance to Insulin (Type II Diabetes and Prediabetes)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Beta-Thalassemia
  • Insulin Resistance
  • PreDiabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE Other: Resistance exercise
2 major muscle groups (lower extremity, chest)
Study Arms  ICMJE
  • Experimental: Exercise
    Resistance exercise 45 min following breakfast
    Intervention: Other: Resistance exercise
  • No Intervention: Control
    No exercise (resting) following breakfast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2019)
6
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2019)
15
Actual Study Completion Date  ICMJE October 30, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03889977
Other Study ID Numbers  ICMJE B-Thalassemia ResEx Glucose
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Athanasios Z. Jamurtas, University of Thessaly
Study Sponsor  ICMJE University of Thessaly
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandra Stamperna, MD UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
PRS Account University of Thessaly
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP