- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01899872
Effect of Acute Exercise on Endothelial Function in Patients With Type 1 Diabetes. (EAEEFD)
Acute Effects of Aerobic and Resistance Exercise on Endothelial Function in Patients With Type 1 Diabetes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to compare the effect of endurance and resistance exercises on endothelial function in patients with type 1 diabetes mellitus (T1DM). For this purpose, the sample size will consist of 15 patients with DM1, aged between 18 and 45 years, which will undertake the two types of exercises, randomly distributed. Ergospirometry testing will be performed in order to assess possible contraindications to the proposed protocol as well as functional capacity, which will be used in prescription of the endurance exercise session. Similarly, a strength maximal testing will be conducted and used in the prescription of the resistance exercise session.
The endothelial function will be evaluated by vascular reactivity of the forearm and circulating endothelial progenitor cells (EPC) counting. To analyze the vascular reactivity of the forearm, non-invasive venous occlusion plethysmography will be used, whereas flow cytometry method will be used to the analysis of the number of circulating EPC. The endurance exercise session will consist of 40 minutes of cycling on heart rate corresponding to 60% of VO2 max. The resistance exercise session will last 40 minutes, consisting of 4 sets of 12 repetitions at 60% of 1RM, in four exercises for lower limbs. The research will be performed at the Exercise Pathophysiology Research Laboratory of the Hospital de Clinicas de Porto Alegre. The investigators expect to find greater increase in the number of circulating EPC after the endurance exercise session, when compared to the benefits obtained from a session of resistance exercise. Likewise, it is expected to find greater benefits in relation to vascular reactivity of the forearm after a session of endurance exercise when compared to a session of resistance exercise. Considering that most part of the studies that analyze the effects of physical exercise on vascular function does not involve patients with DM1, this project aims to provide a clearer picture of the benefits of different exercises in the acute response of endothelial function in these patients.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beatriz D'Agord Schaan, Phd
- Phone Number: 51-33598127
- Email: beatrizschaan@gmail.com
Study Contact Backup
- Name: Gustavo Waclawovsky, Masters student
- Phone Number: 51-33596332
- Email: gwsaude@yahoo.com.br
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
- Recruiting
- Hospital de Clinicas de Porto Alegre
-
Contact:
- Gustavo Waclawovsky, Masters
- Phone Number: 51-33596332
- Email: gwsaude@yahoo.com.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 1 diabetes
- Male gender
- 18-45 years old
Exclusion Criteria:
- Severe autonomic neuropathy
- Diabetic nephropathy established
- Chronic kidney failure
- Limb amputation
- Disabling peripheral arterial disease
- Coronary artery disease
- Heart failure
- Diabetic proliferative retinopathy
- Neoplasms
- Smokers
- Regular physical training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with type 1 diabetes
|
Resistance exercise session consisting of 4 lower-limb exercises, with 4 sets, 12 repetitions per set, at an intensity of 60% of maximal strength.
Aerobic exercise session consisting of 40 minutes of lower-limb bicycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulating endothelial progenitor cells
Time Frame: 10 minutes before the exercise session and 10 minutes after the exercise session.
|
A 20-ml sodium heparin tube will be used and peripheral blood mononuclear cells (PBMC) will be isolated by Ficoll-Hypaque.
Blood samples will be diluted with PBS and layered onto Ficoll-Hypaque in 15-ml tubes.
Tubes will be centrifuged at 400 g for 30 min and the PBMC at the interface will be collected.
Cells will be washed with RPMI 1640 medium and thereafter stained with 5 µl of anti-CD45-FITC , 8 µl of anti-KDR-Alexa Fluor 647, and 5 µl of anti-CD34-PE (all essays from BD, Biosciences, USA).
Thereafter, 50 µl of resuspended cells will be incubated (30 min), and subsequently, 500 µl of PBS will be added for acquisition.
A FACS Calibur flow cytometer will be used with Quest software (BD Biosciences, USA) equipped with 22 mW argon laser tuned at 488 nm, with a total number counted cells of 200,000 on mononuclear cells gate per sample.
Percentage of CD34 positive cells will be calculated based on the number of leukocytes .
|
10 minutes before the exercise session and 10 minutes after the exercise session.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forearm vascular reactivity
Time Frame: 10 minutes before the exercise session and 10 minutes after the exercise session.
|
Forearm blood flow and reactive hyperemia: Forearm blood flow will be measured by venous occlusion plethysmography (D.E Hokanson, USA) at the nondominant forearm. A rapid inflator cuff will be used in the upper arm to occlude venous outflow (50-60 mmHg), and three blood flow recordings will be made each minute during 3 minutes. Thereafter, reactive hyperemia will be measure using an occlusion at 250 mmHg for 5 min, which will be released by 10 seconds intervals for 2 minutes. Reactive hyperemia will be calculated using the peak blood flow after the 5 minutes the occlusion. |
10 minutes before the exercise session and 10 minutes after the exercise session.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100400
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 1 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of California, San FranciscoJuvenile Diabetes Research FoundationCompletedType 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMUnited States, Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Spiden AGDCB Research AGRecruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Type 1 Diabetes Mellitus With HyperglycemiaSwitzerland
-
Hoffmann-La RocheRoche DiagnosticsCompletedDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Germany
Clinical Trials on Resistance exercise session
-
Instituto de Cardiologia do Rio Grande do SulCompletedCardiac Rehabilitation | Aerobic Exercise | Resistance ExerciseBrazil
-
Federal University of UberlandiaCompletedExercise | HemodynamicBrazil
-
Instituto de Cardiologia do Rio Grande do SulRecruiting
-
GlaxoSmithKlineCompletedSports Nutritional SciencesUnited Kingdom
-
University of Nove de JulhoRecruitingPost-Acute COVID-19 SyndromeBrazil
-
University of MichiganEnrolling by invitationCellular Responses Within Skeletal Muscle in Response to Exercise of Different Intensities | Relationship Between the Cellular Responses in Skeletal Muscle and the Changes in the Metabolomic Profile | Changes Within Adipose Tissue in Response to Exercise at the Three Different IntensitiesUnited States
-
USDA Beltsville Human Nutrition Research CenterUnited States Army Research Institute of Environmental MedicineCompleted
-
Swiss Federal Institute of Sport MagglingenRecruiting
-
Herlev and Gentofte HospitalUniversity of CopenhagenCompletedMalignant Melanoma | Cancer of Cervix | Cancer of the Prostate | Cancer, Ovarian | Lymphedema of Leg | Cancer, EndometrialDenmark
-
The University of Tennessee, KnoxvilleCompletedActive Lifestyle Males | Inactive Lifestyle MalesUnited States