Type 1 Diabetes (T1D)STREDIBNCT06774105
Stretching and Diabetes
A study testing Static Stretching in people with Type 1 Diabetes (T1D), run by University of Palermo at 1 site in Italy.
Trial summary
Diabetes mellitus is a persistent disease characterized by alterations in glucose metabolism due to insufficient insulin production or decreased sensitivity to insulin. Exercise is the most effective non-pharmacological intervention to manage glucose levels and improve insulin sensitivity in people with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Static Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 30 Nov 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a diagnosis of type 1 diabetes from at least 1 year
- exercise regularly 2 to 3 times per week
- perform exercise activities other than stretching
- absence of other diabetes-related diseases or comorbidities that prevent them from safely exercising
- HbA1c level ≤ 7%
- BMI ≤ 29.9 kg/m²
- use a CGM reader to monitor glucose levels and daily CHO intake (g) and insulin administration (IU/die).
Who cannot join
- have a diagnosis of type 1 diabetes from less than 1 year
- exercise less or more than 2 to 3 times per week
- perform stretching exercises during the study period
- presence of other diabetes-related diseases or comorbidities that prevent them from safely exercising
- HbA1c level greater than 7%
- BMI greater than 29.9 kg/m²
- not using a CGM reader to monitor glucose levels and daily CHO intake (g) and insulin administration (IU/die).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of 6 Weeks of Static Stretching on Blood Glucose and Insulin Sensitivity in People with Type 1 Diabetes
Diabetes mellitus is a persistent disease characterized by alterations in glucose metabolism due to insufficient insulin production or decreased sensitivity to insulin. Exercise is the most effective non-pharmacological intervention to manage glucose levels and improve insulin sensitivity in people with diabetes. However, little is known regarding the potential effects of stretching. The objective of this study was to understand if six weeks of whole body static stretching could be adopted to manage glycemia and improve insulin sensitivity in a sample of active people with type 1 diabetes.
Read the detailed description
Diabetes mellitus is a persistent disease characterized by alterations in glucose metabolism due to insufficient insulin production or decreased sensitivity to insulin. The main forms are type 1 (T1D) and type 2 diabetes (T2D). T1D, or juvenile diabetes, represents about 5-10% of cases and is characterized by autoimmune destruction of pancreatic beta cells, which are responsible for insulin production. Managing the disease requires constant monitoring and strict control of blood glucose levels. T1D patients need lifelong external insulin administration to compensate for the lack of internal production.
Physical activity (PA) is one of the most effective non-pharmacological methods to prevent diabetes mellitus and treat cardiometabolic conditions associated with this condition. A multicenter study highlighted that regular PA in patients with T1D improves glycemic control. PA influences glucose levels, offering a means to prevent or avoid the worsening of diabetic complications. Regular PA leads to skeletal muscle adaptations that increase muscle sensitivity to glucose uptake, reducing the need for insulin. Despite the benefits of physical activity on cardiometabolic components and quality of life for patients with T1D, over 50% of these patients do not meet the recommended levels of PA.
Among the most popular forms of PA are aerobic and resistance training (RT). Aerobic training is inversely related to the risk of cardiovascular disease and all-cause mortality in T1D, but this latter type of training, especially of medium-low intensity (for long periods), can lead to hypoglycemia, especially if insulin doses and carbohydrate intake are not adjusted to training needs. In contrast, intense RT, generally causes an increase in blood sugar levels due to the release of catecholamines. On the other hand, the benefits of RT in the management and control of T1D are well known. RT of either moderate or high intensity, can offer multiple benefits to people with T1D which include increased muscle strength, improved lipid profile, decreased insulin dosage, and reduced blood glucose levels. A systematic review and meta-analysis found that RT is associated with a significant reduction in glycated haemoglobin (HbA1c), an indicator of long-term glycemic control, compared to control groups. RT can also improve insulin sensitivity in individuals with T1D and reduce the risk of exercise-induced hypoglycemia following aerobic exercise.
Another type of training that has traditionally been used to improve range of movement (ROM) is stretching. Stretching, compared to other forms of exercise, can be performed in a more static setting, and it may be adopted as a suitable alternative for both rehabilitative environments and specific conditions that prevent autonomous exercise. Recent evidence has shifted from the traditional focus of stretching on improving flexibility to broader systemic effects. In this regard, it has been observed that stretching-based interventions can significantly reduce blood glucose levels and HbA1c, regardless of the type of stretching. The review highlighted that the effects were more evident in patients with T2D. Despite the insights provided by this latter review article, there are no known effects of stretching interventions on glucose management and insulin sensitivity in patients with T1D. Since hypoglycemia is the primary barrier to exercise in this population, event that does not occur in T2D patients, it is crucial to evaluate exercise-specific responses in individuals with T1D. Therefore, our study aims to determine if a 6-week whole body static stretching (SS) intervention can be used as an exercise intervention to manage glycemia and improve insulin sensitivity in a sample of active people with T1D.
Data concerning blood glucose levels (mg/dl), daily CHO consumption and UI/die will be extracted from the continuous glucose monitor of each participant. CGM systems allow people with T1D to monitor in real-time changes in blood glucose. All participants have to be experienced in carbohydrate counting. However, to increase consistency a mobile phone app will be recommended (Yazio for Ios and Android) that extracted the grams of CHO by providing the amount and type of food ingested. UI/die will also be calculated as a sum of basal and bolus insulin units injected per day. The insulin sensitivity index (IS) will then be calculated as the CHO-to-UI/die ratio, which was calculated as the total grams of CHO consumed during one day to the total UI/die.
Participants will be assigned to two groups: a CC and an experimental group. The CC will maintaine their usual exercise routine, while the experimental group will include to their usual exercise routine, during non-training days, a 6-week SS exercise protocol. The protocol will consist in 2 sessions per week, each comprising 8 exercises targeting all major muscle groups: 1) Hamstrings, 2) Knee Extensors, 3) Dorsal muscles, 4) Pectoralis muscles, 5) Elbow Flexors (biceps), 6) Elbow Extensors (triceps), 7) Adductors, and one day 8a) Spine Extensors while the second 8b) Spine Flexors. Each exercise 4 sets of 30 seconds of SS and 30 seconds of rest. Before each session, blood glucose levels will be monitored to ensure stability. In cases participants will show signs of impending hypoglycemia, sessions will be interrupted.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Static Stretching
- Keywords
- Type 1 diabetes, stretching, insulin sensitivity, insulin requirements, blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static StretchingOther
The protocol consisted in 2 sessions per week, each comprising 8 exercises of static stretching targeting all major muscle groups: 1) Hamstrings, 2) Knee Extensors, 3) Dorsal muscles, 4) Pectoralis muscles, 5) Elbow Flexors (biceps), 6) Elbow Extensors (triceps), 7) Adductors, and one day 8a) Spine Extensors while the second 8b) Spine Flexors. Each exercise involved 4 sets of 30 seconds of SS and 30 seconds of rest.
| Study group | Role | What they receive |
|---|---|---|
| CC | No intervention | The participants continue with their own activities for the study period |
| SS | Experimental | The participants undergo a static stretching protocol twice a week for six weeks. The protocol consists in 2 sessions per week, each comprising 8 exercises targeting all major muscle groups: 1) Hamstrings, 2) Knee Extensors, 3) Dorsal muscles, 4) Pectoralis muscles, 5) Elbow Flexors (biceps), 6) Elbow Extensors (triceps), 7) Adductors, and one day 8a) Spine Extensors while the second 8b) Spine Flexors. Each exercise involved 4 sets of 30 seconds of SS and 30 seconds of rest. Receives: Other: Static Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (2)
Insulin Requirements
Measured: From enrollment to the end of treatment at 6 weeks
Insulin Sensitivity
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Jun 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewan Thomas, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774105
- Sponsor's protocol ID
- 260-2024
- Acronym
- STREDIB
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be publicly available; however, data will be shared upon request with the corresponding author if required.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 6 Weeks of Static Stretching on Blood Glucose and Insulin Sensitivity in People with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06774105
- Acronym / sponsor ID
- STREDIB / 260-2024
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Type 1 diabetes, stretching, insulin sensitivity, insulin requirements, blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 14 Jan 2025 (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.
Diabetes mellitus is a persistent disease characterized by alterations in glucose metabolism due to insufficient insulin production or decreased sensitivity to insulin. Exercise is the most effective non-pharmacological intervention to manage glucose levels and improve insulin sensitivity in people with diabetes. However, little is known regarding the potential effects of stretching. The objective of this study was to understand if six weeks of whole body static stretching could be adopted to manage glycemia and improve insulin sensitivity in a sample of active people with type 1 diabetes.
Detailed description
Diabetes mellitus is a persistent disease characterized by alterations in glucose metabolism due to insufficient insulin production or decreased sensitivity to insulin. The main forms are type 1 (T1D) and type 2 diabetes (T2D). T1D, or juvenile diabetes, represents about 5-10% of cases and is characterized by autoimmune destruction of pancreatic beta cells, which are responsible for insulin production. Managing the disease requires constant monitoring and strict control of blood glucose levels. T1D patients need lifelong external insulin administration to compensate for the lack of internal production.
Physical activity (PA) is one of the most effective non-pharmacological methods to prevent diabetes mellitus and treat cardiometabolic conditions associated with this condition. A multicenter study highlighted that regular PA in patients with T1D improves glycemic control. PA influences glucose levels, offering a means to prevent or avoid the worsening of diabetic complications. Regular PA leads to skeletal muscle adaptations that increase muscle sensitivity to glucose uptake, reducing the need for insulin. Despite the benefits of physical activity on cardiometabolic components and quality of life for patients with T1D, over 50% of these patients do not meet the recommended levels of PA.
Among the most popular forms of PA are aerobic and resistance training (RT). Aerobic training is inversely related to the risk of cardiovascular disease and all-cause mortality in T1D, but this latter type of training, especially of medium-low intensity (for long periods), can lead to hypoglycemia, especially if insulin doses and carbohydrate intake are not adjusted to training needs. In contrast, intense RT, generally causes an increase in blood sugar levels due to the release of catecholamines. On the other hand, the benefits of RT in the management and control of T1D are well known. RT of either moderate or high intensity, can offer multiple benefits to people with T1D which include increased muscle strength, improved lipid profile, decreased insulin dosage, and reduced blood glucose levels. A systematic review and meta-analysis found that RT is associated with a significant reduction in glycated haemoglobin (HbA1c), an indicator of long-term glycemic control, compared to control groups. RT can also improve insulin sensitivity in individuals with T1D and reduce the risk of exercise-induced hypoglycemia following aerobic exercise.
Another type of training that has traditionally been used to improve range of movement (ROM) is stretching. Stretching, compared to other forms of exercise, can be performed in a more static setting, and it may be adopted as a suitable alternative for both rehabilitative environments and specific conditions that prevent autonomous exercise. Recent evidence has shifted from the traditional focus of stretching on improving flexibility to broader systemic effects. In this regard, it has been observed that stretching-based interventions can significantly reduce blood glucose levels and HbA1c, regardless of the type of stretching. The review highlighted that the effects were more evident in patients with T2D. Despite the insights provided by this latter review article, there are no known effects of stretching interventions on glucose management and insulin sensitivity in patients with T1D. Since hypoglycemia is the primary barrier to exercise in this population, event that does not occur in T2D patients, it is crucial to evaluate exercise-specific responses in individuals with T1D. Therefore, our study aims to determine if a 6-week whole body static stretching (SS) intervention can be used as an exercise intervention to manage glycemia and improve insulin sensitivity in a sample of active people with T1D.
Data concerning blood glucose levels (mg/dl), daily CHO consumption and UI/die will be extracted from the continuous glucose monitor of each participant. CGM systems allow people with T1D to monitor in real-time changes in blood glucose. All participants have to be experienced in carbohydrate counting. However, to increase consistency a mobile phone app will be recommended (Yazio for Ios and Android) that extracted the grams of CHO by providing the amount and type of food ingested. UI/die will also be calculated as a sum of basal and bolus insulin units injected per day. The insulin sensitivity index (IS) will then be calculated as the CHO-to-UI/die ratio, which was calculated as the total grams of CHO consumed during one day to the total UI/die.
Participants will be assigned to two groups: a CC and an experimental group. The CC will maintaine their usual exercise routine, while the experimental group will include to their usual exercise routine, during non-training days, a 6-week SS exercise protocol. The protocol will consist in 2 sessions per week, each comprising 8 exercises targeting all major muscle groups: 1) Hamstrings, 2) Knee Extensors, 3) Dorsal muscles, 4) Pectoralis muscles, 5) Elbow Flexors (biceps), 6) Elbow Extensors (triceps), 7) Adductors, and one day 8a) Spine Extensors while the second 8b) Spine Flexors. Each exercise 4 sets of 30 seconds of SS and 30 seconds of rest. Before each session, blood glucose levels will be monitored to ensure stability. In cases participants will show signs of impending hypoglycemia, sessions will be interrupted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CC | No intervention | –The participants continue with their own activities for the study period |
| SS | Experimental | Other: Static StretchingThe participants undergo a static stretching protocol twice a week for six weeks. The protocol consists in 2 sessions per week, each comprising 8 exercises targeting all major muscle groups: 1) Hamstrings, 2) Knee Extensors, 3) Dorsal muscles, 4) Pectoralis muscles, 5) Elbow Flexors (biceps), 6) Elbow Extensors (triceps), 7) Adductors, and one day 8a) Spine Extensors while the second 8b) Spine Flexors. Each exercise involved 4 sets of 30 seconds of SS and 30 seconds of rest. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- have a diagnosis of type 1 diabetes from at least 1 year
- exercise regularly 2 to 3 times per week
- perform exercise activities other than stretching
- absence of other diabetes-related diseases or comorbidities that prevent them from safely exercising
- HbA1c level ≤ 7%
Key exclusion criteria (7 listed)
- have a diagnosis of type 1 diabetes from less than 1 year
- exercise less or more than 2 to 3 times per week
- perform stretching exercises during the study period
- presence of other diabetes-related diseases or comorbidities that prevent them from safely exercising
- HbA1c level greater than 7%
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 |
|---|---|---|
| Static StretchingThe protocol consisted in 2 sessions per week, each comprising 8 exercises of static stretching targeting all major muscle groups: 1) Hamstrings, 2) Knee Extensors, 3) Dorsal muscles, 4) Pectoralis muscles, 5) Elbow Flexors (biceps), 6) Elbow Extensors (triceps), 7) Adductors, and one day 8a) Spine Extensors while the second 8b) Spine Flexors. Each exercise involved 4 sets of 30 seconds of SS and 30 seconds of rest. | Other | SS |
Primary outcome
Blood Glucose
Time frame: From enrollment to the end of treatment at 6 weeks
2 secondary outcomes
Insulin Requirements
Time frame: From enrollment to the end of treatment at 6 weeks
Insulin Sensitivity
Time frame: From enrollment to the end of treatment at 6 weeks
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 14 Jan 2025.
- Individual participant dataSharing planned: No. The data will not be publicly available; however, data will be shared upon request with the corresponding author if required.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Stretching in people with Type 1 Diabetes (T1D), run by University of Palermo at 1 site in Italy.
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 7 inclusion and 7 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 14 Jan 2025. 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 Italy. 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?
Blood Glucose (time frame: From enrollment to the end of treatment at 6 weeks). 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 14 Jan 2025.