NCT01899872

Brief Summary

The aim of this study is to evaluate the effect of a single session of aerobic plus resistance exercises on the vascular function of patients with type 1 diabetes mellitus. The investigators hypothesize that a single aerobic exercise session would promote greater benefit in vascular function of patients with type 1 diabetes, as compared with the resistive exercise session.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

1.9 years

First QC Date

July 8, 2013

Last Update Submit

July 11, 2013

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes MellitusEndothelial progenitor cellEndothelial functionExercise

Outcome Measures

Primary Outcomes (1)

  • Circulating endothelial progenitor cells

    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 Outcomes (1)

  • Forearm vascular reactivity

    10 minutes before the exercise session and 10 minutes after the exercise session.

Study Arms (1)

Patients with type 1 diabetes

EXPERIMENTAL

Patients with type 1 diabetes

Behavioral: Resistance exercise sessionBehavioral: Aerobic exercise session

Interventions

Resistance exercise sessionBEHAVIORAL

Resistance exercise session consisting of 4 lower-limb exercises, with 4 sets, 12 repetitions per set, at an intensity of 60% of maximal strength.

Patients with type 1 diabetes
Aerobic exercise sessionBEHAVIORAL

Aerobic exercise session consisting of 40 minutes of lower-limb bicycle.

Patients with type 1 diabetes

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 1 diabetes
  • Male gender
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Beatriz D'Agord Schaan, Phd

CONTACT

51-33598127beatrizschaan@gmail.com

Gustavo Waclawovsky, Masters student

CONTACT

51-33596332gwsaude@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Beatriz D'Agord Schaan

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 16, 2013

Study Start

December 1, 2011

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations

BR(1)