Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic Individuals

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic and Hypertensive Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400515
• Other study ID #: 030/2007
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: March 23, 2015
• Start date: August 2007
• Est. completion date: June 2008

Study information

• Verified date: March 2015
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

This quasi-experimental study aim to performed a 12-week training program (3 times/week, 60 minutes per session) which consisted of a supervised moderate aerobic exercise previously determined (50% to 70% of maximal Heart Rate) in women with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• the use of insulin and beta-blocker medications and

• the functional inability to perform exercise

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Salivary cortisol	After practicing the exercise for 3 months, patients were submitted to a new saliva collection for the salivary cortisol measure.	3 months	No
Other	Hospital Anxiety and Depression scale (HADS)	After 3 months of the physical exercise, the HADS was evaluated.	3 months	No
Primary	Glucose levels	After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Glucose test.	3 months	No
Secondary	Systolic and Diastolic blood pressure	Change in Systolic and Diastolic blood pressure were evaluated before and after physical exercise, during 3 months.	3 months	No
Secondary	Heart Rate measurement	Change in heart rate was evaluated before, during and after physical exercise, during 3 months.	3 months	No
Secondary	Glycated hemoglobin levels	After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Glycated hemoglobin test.	3 months	No
Secondary	Proteinuria levels	After practicing the exercise for 3 months, patients were submitted to a new collection of blood for proteinuria test.	3 months	No
Secondary	Triglycerides levels	After practicing the exercise for 3 months, patients were submitted to a new collection of blood for triglycerides test.	3 months	No
Secondary	High Density Level (HDL) Cholesterol levels	After practicing the exercise for 3 months, patients were submitted to a new collection of blood for High Density Level Cholesterol test.	3 months	No
Secondary	Low Density Level (LDL) Cholesterol levels	After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Low Density Level Cholesterol test.	3 months	No