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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Italy1 site
  • University of Palermo

    Palermo, IT, 90133

Other trials in Italy

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.

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 groups in NCT06774105
Study groupRoleWhat they receive
CCNo interventionThe participants continue with their own activities for the study period
SSExperimentalThe 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.

  1. Blood Glucose

    Measured: From enrollment to the end of treatment at 6 weeks

Secondary outcomes (2)
  1. Insulin Requirements

    Measured: From enrollment to the end of treatment at 6 weeks

  2. 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.

  1. First posted14 Jan 2025
  2. Study start1 Jun 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

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)
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.

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.

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