Clinical trial NCT03889977: Resistance Exercise on Postprandial Hyperglycemia in Patients With B-thalassemia Exhibiting Resistance to Insulin
Official title: The Effect of Resistance Exercise on Postprandial Hyperglycemia in Patients With B-thalassemia Exhibiting Resistance to Insulin (Type II Diabetes and Prediabetes)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta-Thalassemia
Insulin Resistance
PreDiabetes
Diabetes Mellitus, Type 2
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 6
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in blood glucose
timeFrame: 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
measure: Changes in blood insulin
timeFrame: 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
measure: Changes in blood triglycerides
timeFrame: 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 outcomes:
measure: Body mass
timeFrame: At the baseline and before each trial
measure: Body height
timeFrame: At the baseline
measure: Body fat
timeFrame: Before each trial
measure: Resting heart rate
timeFrame: At the baseline and before each trial
measure: Heart rate during exercise
timeFrame: During exercise in each trial
measure: Changes in total antioxidant capacity
timeFrame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
measure: Changes in reduced glutathione (GSH)
timeFrame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
measure: Changes in catalase
timeFrame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
measure: Changes in uric acid
timeFrame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
measure: Changes in protein carbonyls
timeFrame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
measure: Changes in substances that react with thiobarbituric acid (TBARS)
timeFrame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Other outcomes:
Locations:
city: Tríkala
country: Greece
facility: Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Study officials:
affiliation: UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
name: Alexandra Stamperna, MD
role: PRINCIPAL_INVESTIGATOR
References: