NCT06774105

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 8, 2025

Last Update Submit

January 8, 2025

Conditions

Keywords

Type 1 diabetesstretchinginsulin sensitivityinsulin requirementsblood glucose

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose

    From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (2)

  • Insulin Requirements

    From enrollment to the end of treatment at 6 weeks

  • Insulin Sensitivity

    From enrollment to the end of treatment at 6 weeks

Study Arms (2)

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.

Other: Static Stretching

Interventions

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.

SS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Palermo

Palermo, IT, 90133, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 14, 2025

Study Start

June 1, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

The data will not be publicly available; however, data will be shared upon request with the corresponding author if required.

Locations