NCT02441504

Brief Summary

Background: The aim of the present study was to evaluate the changes in the microvascular density and reactivity in patients with type 1 diabetes (T1D) resulting from low intensity chronic exercise training. Methods: This study included 22 (34 ± 7 years) consecutive outpatients with T1D and disease duration \> six years. We used intravital video-microscopy to measure the basal skin capillary density as well as capillary recruitment using post-occlusive reactive hyperemia (PORH) in the dorsum of the fingers. Endothelium-dependent and -independent vasodilation of the skin microcirculation was evaluated in the forearm with a laser Doppler perfusion monitoring (LDPM) system in combination with acetylcholine and sodium nitroprusside iontophoresis, PORH and local thermal hyperemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

8 months

First QC Date

April 28, 2015

Last Update Submit

May 11, 2015

Conditions

Keywords

Exercise trainingmicrovascular rarefaction

Outcome Measures

Primary Outcomes (1)

  • Change in Cutaneous Capillary Density in twelve weeks of aerobic physical activity

    Chronic aerobic exercise has been involved in angiogenic processes that result in increased perfusion and capillary density. We believe that 12 weeks of aerobic exercise of low intensity is also able to exert the same effects in type 1diabetics patients. The microvascular cutaneous reactivity was studied by laser Doppler perfusion monitoring (LDPM), a method that has previously been standardized and validated. The capillary density, defined as the number of perfused capillaries per mm2 of skin area, was assessed by high-resolution intra-vital color microscopy using a video microscopy system with an epi-illuminated fiber optic microscope containing a 100-W mercury vapor lamp light source and an M200 objective with a final magnification of 200X.

    before and after 12 weeks of aerobic physical activity

Study Arms (1)

Low intensity exercise

ACTIVE COMPARATOR

physical inactivity

Other: Low intensity Exercise

Interventions

aerobic exercise training using walking and running

Low intensity exercise

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with type 1 diabetes diagnosed for more than 6 years
  • Age: between 25 and 50 years of age

You may not qualify if:

  • Chronic renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Matheus AS, Tibirica E, da Silva PB, de Fatima Bevilacqua da Matta M, Gomes MB. Uric acid levels are associated with microvascular endothelial dysfunction in patients with Type 1 diabetes. Diabet Med. 2011 Oct;28(10):1188-93. doi: 10.1111/j.1464-5491.2011.03349.x.

    PMID: 21658123BACKGROUND
  • Gomes MB, Matheus AS, Tibirica E. Evaluation of microvascular endothelial function in patients with type 1 diabetes using laser-Doppler perfusion monitoring: which method to choose? Microvasc Res. 2008 Aug;76(2):132-3. doi: 10.1016/j.mvr.2008.04.003. Epub 2008 Apr 25.

    PMID: 18533196BACKGROUND
  • Antonios TF, Nama V, Wang D, Manyonda IT. Microvascular remodelling in preeclampsia: quantifying capillary rarefaction accurately and independently predicts preeclampsia. Am J Hypertens. 2013 Sep;26(9):1162-9. doi: 10.1093/ajh/hpt087. Epub 2013 Jun 11.

    PMID: 23757401BACKGROUND
  • Antonios TF, Kaski JC, Hasan KM, Brown SJ, Singer DR. Rarefaction of skin capillaries in patients with anginal chest pain and normal coronary arteriograms. Eur Heart J. 2001 Jul;22(13):1144-8. doi: 10.1053/euhj.2000.2442.

    PMID: 11428855BACKGROUND
  • Nama V, Manyonda IT, Onwude J, Antonios TF. Structural capillary rarefaction and the onset of preeclampsia. Obstet Gynecol. 2012 May;119(5):967-74. doi: 10.1097/AOG.0b013e31824ea092.

    PMID: 22525907BACKGROUND
  • de Moraes R, Van Bavel D, Gomes MB, Tibirica E. Effects of non-supervised low intensity aerobic excise training on the microvascular endothelial function of patients with type 1 diabetes: a non-pharmacological interventional study. BMC Cardiovasc Disord. 2016 Jan 27;16:23. doi: 10.1186/s12872-016-0191-9.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Microvascular Rarefaction

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. PhD

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 12, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

May 13, 2015

Record last verified: 2015-05