Beta-ThalassemiaNCT03889977
Resistance Exercise on Postprandial Hyperglycemia in Patients With B-thalassemia Exhibiting Resistance to Insulin
A study testing Resistance exercise in people with Beta-Thalassemia and Insulin Resistance, run by University of Thessaly at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Beta-Thalassemia, Insulin Resistance, PreDiabetes
- What is being tested?
- Resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGreece
- Study dates
- 11 Feb 2019to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with Beta-Thalassemia
- Diagnosed with prediabetes or type II diabetes
Who cannot join
- Heart failure
- Hypertension
- Muscular, neuromuscular, bone disorders
- Muscular, bone or other injuries that do not allowed safe participation to exercise
Trial locations and contacts
1 site in 1 country.
Greece1 site
Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Trikala, 42100
About this study
Official title: The Effect of Resistance Exercise on Postprandial Hyperglycemia in Patients With B-thalassemia Exhibiting Resistance to Insulin (Type II Diabetes and Prediabetes)
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.
Read the 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.
- Being tested
- Resistance exercise
- Medical subject headings
- beta-Thalassemia, Insulin Resistance, Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
2 major muscle groups (lower extremity, chest)
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Resistance exercise 45 min following breakfast Receives: Other: Resistance exercise |
| Control | No intervention | No exercise (resting) following breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood glucose
Concentration of blood glucose will be measured in serum
Measured: 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
Changes in blood insulin
Concentration of blood insulin will be measured in serum
Measured: 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
Changes in blood triglycerides
Concentration of blood triglycerides will be measured in serum
Measured: 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 (11)
Body mass
Body mass (kg) will be measured with Beam Balance-Stadiometer (SECA, Vogel \& Halke, Hamburg, Germany)
Measured: At the baseline and before each trial
Body height
Body height (m) will be measured with Beam Balance-Stadiometer (SECA, Vogel \& Halke, Hamburg, Germany)
Measured: At the baseline
Body fat
Body fat (kg and percentage) will be measured with Dual-emission X-ray absorptiometry (GE Healthcare, Lunar DPX-NT)
Measured: Before each trial
Resting heart rate
Resting heart rate (beats per minute) will be monitored using Team Polar (Polar Electro Oy, Kempele, Finland)
Measured: At the baseline and before each trial
Heart rate during exercise
Heart rate (beats per minute) will be monitored using continuous heart rate measurements (Team Polar, Polar Electro Oy, Kempele, Finland)
Measured: During exercise in each trial
Changes in total antioxidant capacity
Concentration of total antioxidant capacity will be measured in serum
Measured: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Changes in reduced glutathione (GSH)
Concentration of GSH will be measured in erythrocyte lysate
Measured: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Changes in catalase
Concentration of catalase will be measured in erythrocyte lysate
Measured: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Changes in uric acid
Concentration of uric acid will be measured in serum
Measured: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Changes in protein carbonyls
Concentration of protein carbonyls will be measured in plasma
Measured: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Changes in substances that react with thiobarbituric acid (TBARS)
Concentration of TBARS will be measured in plasma
Measured: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start11 Feb 2019
- Primary completion30 Aug 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta-ThalassemiaStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios Z. Jamurtas, University of Thessaly
- Investigators
- Alexandra Stamperna, MD, Principal investigator, UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889977
- Sponsor's protocol ID
- B-Thalassemia ResEx Glucose
- Status last verified
- Jan 2020
- First submitted
- 22 Mar 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistance Exercise on Postprandial Hyperglycemia in Patients With B-thalassemia Exhibiting Resistance to Insulin (Type II Diabetes and Prediabetes)
- ClinicalTrials.gov ID
- NCT03889977
- Acronym / sponsor ID
- B-Thalassemia ResEx Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Resistance exerciseResistance exercise 45 min following breakfast |
| Control | No intervention | –No exercise (resting) following breakfast |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with Beta-Thalassemia
- Diagnosed with prediabetes or type II diabetes
Key exclusion criteria (4 listed)
- Heart failure
- Hypertension
- Muscular, neuromuscular, bone disorders
- Muscular, bone or other injuries that do not allowed safe participation to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercise2 major muscle groups (lower extremity, chest) | Other | Exercise |
Primary outcome
Changes in blood glucose
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
Concentration of blood glucose will be measured in serum
Changes in blood insulin
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
Concentration of blood insulin will be measured in serum
Changes in blood triglycerides
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
Concentration of blood triglycerides will be measured in serum
11 secondary outcomes
Body mass
Time frame: At the baseline and before each trial
Body height
Time frame: At the baseline
Body fat
Time frame: Before each trial
Resting heart rate
Time frame: At the baseline and before each trial
Heart rate during exercise
Time frame: During exercise in each trial
Changes in total antioxidant capacity
Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Changes in reduced glutathione (GSH)
Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Changes in catalase
Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Changes in uric acid
Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Changes in protein carbonyls
Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Changes in substances that react with thiobarbituric acid (TBARS)
Time frame: Pre-breakfast (fasting glucose), immediately post-exercise, 24 hours post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Stamperna, MD principal investigator
UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise in people with Beta-Thalassemia and Insulin Resistance, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood glucose (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.