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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889977
• Other study ID #: B-Thalassemia ResEx Glucose
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2020
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Beta-Thalassemia
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Hyperglycemia
• Insulin Resistance
• PreDiabetes
• Prediabetic State
• Thalassemia

Intervention

Other:
• Resistance exercise
2 major muscle groups (lower extremity, chest)

Locations

Country	Name	City	State
Greece	Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly	Tríkala

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Body mass	Body mass (kg) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany)	At the baseline and before each trial
Secondary	Body height	Body height (m) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany)	At the baseline
Secondary	Body fat	Body fat (kg and percentage) will be measured with Dual-emission X-ray absorptiometry (GE Healthcare, Lunar DPX-NT)	Before each trial
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in catalase	Concentration of catalase will be measured in erythrocyte lysate	Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Secondary	Changes in uric acid	Concentration of uric acid will be measured in serum	Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Secondary	Changes in protein carbonyls	Concentration of protein carbonyls will be measured in plasma	Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Secondary	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