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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03889977
Enrollment
6
Registered
2019-03-26
Start date
2019-02-11
Completion date
2019-10-30
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta-Thalassemia, Diabetes Mellitus, Type 2, Insulin Resistance, 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.

Interventions

OTHERResistance exercise

2 major muscle groups (lower extremity, chest)

Sponsors

University of Thessaly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in blood insulinPre-breakfast (fasting glucose), 45 min post-breakfast (before exercise), immediately post-exercise, 1 hour post-exercise, 2 hours post-exercise, 24 hours post-exerciseConcentration of blood insulin will be measured in serum
Changes in blood triglyceridesPre-breakfast (fasting glucose), 45 min post-breakfast (before exercise), immediately post-exercise, 1 hour post-exercise, 2 hours post-exercise, 24 hours post-exerciseConcentration of blood triglycerides will be measured in serum
Changes in blood glucosePre-breakfast (fasting glucose), 45 min post-breakfast (before exercise), immediately post-exercise, 1 hour post-exercise, 2 hours post-exercise, 24 hours post-exerciseConcentration of blood glucose will be measured in serum

Secondary

MeasureTime frameDescription
Resting heart rateAt the baseline and before each trialResting heart rate (beats per minute) will be monitored using Team Polar (Polar Electro Oy, Kempele, Finland)
Heart rate during exerciseDuring exercise in each trialHeart rate (beats per minute) will be monitored using continuous heart rate measurements (Team Polar, Polar Electro Oy, Kempele, Finland)
Changes in total antioxidant capacityPre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exerciseConcentration of total antioxidant capacity will be measured in serum
Changes in reduced glutathione (GSH)Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exerciseConcentration of GSH will be measured in erythrocyte lysate
Body massAt the baseline and before each trialBody mass (kg) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany)
Changes in uric acidPre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exerciseConcentration of uric acid will be measured in serum
Changes in protein carbonylsPre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exerciseConcentration of protein carbonyls will be measured in plasma
Changes in substances that react with thiobarbituric acid (TBARS)Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exerciseConcentration of TBARS will be measured in plasma
Changes in catalasePre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exerciseConcentration of catalase will be measured in erythrocyte lysate
Body heightAt the baselineBody height (m) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany)
Body fatBefore each trialBody fat (kg and percentage) will be measured with Dual-emission X-ray absorptiometry (GE Healthcare, Lunar DPX-NT)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026