NCT02400515

Brief Summary

This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on glucose and lipid metabolism as well as the scales of anxiety and depression and levels of salivary cortisol in women with type 2 diabetes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

August 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

March 5, 2015

Last Update Submit

March 23, 2015

Conditions

Diabetes Mellitus, Type 2

Keywords

ExerciseExercise TherapyDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Glucose levels

    After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Glucose test.

    3 months

Secondary Outcomes (7)

  • Systolic and Diastolic blood pressure

    3 months

  • Heart Rate measurement

    3 months

  • Glycated hemoglobin levels

    3 months

  • Proteinuria levels

    3 months

  • Triglycerides levels

    3 months

  • +2 more secondary outcomes

Other Outcomes (2)

  • Salivary cortisol

    3 months

  • Hospital Anxiety and Depression scale (HADS)

    3 months

Study Arms (1)

Moderate Exercise

OTHER

Aerobic physical exercise was applied during 3 months, 3x/week on women with type 2 diabetic. The evaluation occurred before and after exercise in the same (and only) group, considering that this is a quasi-experimental study.

Other: Exercise

Interventions

ExerciseOTHER

This is a quasi-experimental study and the same group was evaluated before and after the exercise.

Moderate Exercise

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having normal physical examinations,
  • no participation in regular, moderate or intensive exercise for at least 6 months before the study and
  • not be following a diet

You may not qualify if:

  • the use of insulin and beta-blocker medications and
  • the functional inability to perform exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 27, 2015

Study Start

August 1, 2007

Primary Completion

March 1, 2008

Study Completion

June 1, 2008

Last Updated

March 27, 2015

Record last verified: 2015-03