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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Insulin Resistance; PreDiabetes; Beta-Thalassemia
• Intervention / Treatment: Other: Resistance exercise

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: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Tríkala, Greece, 42100
    • Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Principal Investigator: Alexandra Stamperna, MD, UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hematologic Diseases; Diabetes Mellitus; Genetic Diseases, Inborn; Anemia; Hyperinsulinism; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Hyperglycemia; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance; Insulin Resistance; Thalassemia; beta-Thalassemia
• Other Study ID Numbers: B-Thalassemia ResEx Glucose

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No