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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03889977
Other study ID # B-Thalassemia ResEx Glucose
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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