search
Back to results

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

Primary Purpose

Beta-Thalassemia, Insulin Resistance, PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Resistance exercise
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Beta-Thalassemia

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

Resistance exercise 45 min following breakfast

No exercise (resting) following breakfast

Outcomes

Primary Outcome Measures

Changes in blood glucose
Concentration of blood glucose will be measured in serum
Changes in blood insulin
Concentration of blood insulin will be measured in serum
Changes in blood triglycerides
Concentration of blood triglycerides will be measured in serum

Secondary Outcome Measures

Body mass
Body mass (kg) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany)
Body height
Body height (m) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany)
Body fat
Body fat (kg and percentage) will be measured with Dual-emission X-ray absorptiometry (GE Healthcare, Lunar DPX-NT)
Resting heart rate
Resting heart rate (beats per minute) will be monitored using Team Polar (Polar Electro Oy, Kempele, Finland)
Heart rate during exercise
Heart rate (beats per minute) will be monitored using continuous heart rate measurements (Team Polar, Polar Electro Oy, Kempele, Finland)
Changes in total antioxidant capacity
Concentration of total antioxidant capacity will be measured in serum
Changes in reduced glutathione (GSH)
Concentration of GSH will be measured in erythrocyte lysate
Changes in catalase
Concentration of catalase will be measured in erythrocyte lysate
Changes in uric acid
Concentration of uric acid will be measured in serum
Changes in protein carbonyls
Concentration of protein carbonyls will be measured in plasma
Changes in substances that react with thiobarbituric acid (TBARS)
Concentration of TBARS will be measured in plasma

Full Information

First Posted
March 22, 2019
Last Updated
January 14, 2020
Sponsor
University of Thessaly
search

1. Study Identification

Unique Protocol Identification Number
NCT03889977
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Beta-Thalassemia, Insulin Resistance, PreDiabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Resistance exercise 45 min following breakfast
Arm Title
Control
Arm Type
No Intervention
Arm Description
No exercise (resting) following breakfast
Intervention Type
Other
Intervention Name(s)
Resistance exercise
Intervention Description
2 major muscle groups (lower extremity, chest)
Primary Outcome Measure Information:
Title
Changes in blood glucose
Description
Concentration of blood glucose will be measured in serum
Time Frame
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
Title
Changes in blood insulin
Description
Concentration of blood insulin will be measured in serum
Time Frame
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
Title
Changes in blood triglycerides
Description
Concentration of blood triglycerides will be measured in serum
Time Frame
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 Measure Information:
Title
Body mass
Description
Body mass (kg) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany)
Time Frame
At the baseline and before each trial
Title
Body height
Description
Body height (m) will be measured with Beam Balance-Stadiometer (SECA, Vogel & Halke, Hamburg, Germany)
Time Frame
At the baseline
Title
Body fat
Description
Body fat (kg and percentage) will be measured with Dual-emission X-ray absorptiometry (GE Healthcare, Lunar DPX-NT)
Time Frame
Before each trial
Title
Resting heart rate
Description
Resting heart rate (beats per minute) will be monitored using Team Polar (Polar Electro Oy, Kempele, Finland)
Time Frame
At the baseline and before each trial
Title
Heart rate during exercise
Description
Heart rate (beats per minute) will be monitored using continuous heart rate measurements (Team Polar, Polar Electro Oy, Kempele, Finland)
Time Frame
During exercise in each trial
Title
Changes in total antioxidant capacity
Description
Concentration of total antioxidant capacity will be measured in serum
Time Frame
Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Title
Changes in reduced glutathione (GSH)
Description
Concentration of GSH will be measured in erythrocyte lysate
Time Frame
Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Title
Changes in catalase
Description
Concentration of catalase will be measured in erythrocyte lysate
Time Frame
Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Title
Changes in uric acid
Description
Concentration of uric acid will be measured in serum
Time Frame
Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Title
Changes in protein carbonyls
Description
Concentration of protein carbonyls will be measured in plasma
Time Frame
Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Title
Changes in substances that react with thiobarbituric acid (TBARS)
Description
Concentration of TBARS will be measured in plasma
Time Frame
Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Stamperna, MD
Organizational Affiliation
UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
City
Tríkala
ZIP/Postal Code
42100
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs