Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000217303
Ethics application status
Approved
Date submitted
16/04/2008
Date registered
21/04/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of exercise therapy on lipid profile and oxidative stress indicators in patients with type 2 diabetes
Scientific title
Effect of exercise therapy on lipid profile and oxidative stress indicators in patients with type 2 diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 3056 0
Condition category
Condition code
Metabolic and Endocrine 3213 3213 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention for Group 1: Each yoga session consisted of 20 minutes of pranayamas (breath-control exercises), 25 minutes of dynamic warm-up exercises, 60 minutes of asanas (yogic postures), and 15 minutes of supine relaxation in savasana (corpse pose). A single session last for 2 hours. The Hatha yoga exercise sessions were conducted once per week for six months. Daily home exercise 3 – 4 times per week for 1 hour in the same Rate of Perceived Exertion was encouraged.

Intervention for Group 2: The conventional physical training sessions consisted of 15 minutes of warm up exercises, 30 minutes of aerobic walking on an outdoor 400-meter track, 20 minutes of body flexibility exercises, 20 minutes of aerobic dance, 25 minutes of games and 10 minutes of warm down exercises. A single session last for 2 hours. The physical training exercise sessions were conducted once per week for six months. Daily home exercise 3 – 4 times per week for 1 hour in the same Rate of Perceived Exertion was encouraged.

The duration of the study was for six months.
Intervention code [1] 2804 0
Lifestyle
Comparator / control treatment
The control group was not engaged in any kind of active exercise intervention during the entire study period.
Control group
Active

Outcomes
Primary outcome [1] 4097 0
The fasting blood glucose concentration for each group was determined by using the Reflolux S type 1172115 glucometers. Total cholesterol, triglyceride and high density lipoprotein (HDL) were determined by enzymatic methods. High density lipoprotein was measured after precipitating very low density lipoprotein (VLDL) and low density lipoprotein (LDL) cholesterol in the presence of magnesium ions. The LDL fraction was calculated by the Friedwald formula.
Changes in fasting blood glucose, total cholesterol, low density lipoprotein and high density lipoprotein cholesterol from baseline to 6 months.
Timepoint [1] 4097 0
At baseline, 3 and 6 months
Secondary outcome [1] 6897 0
Malondialdehyde concentration in the serum was measured spectrophotometrically. Protein oxidation is based on the detection of the carbonyl group that appears as a result of the oxidation of lateral chains of certain amino acids. Plasma carbonyl group levels were evaluated following the 2,4-dinitrophenylhydrazine (2,4-DNP) assay. The superoxide dismutase activity was determined by inhibition of pyrogallin and catalase activity was measured by ultraviolet method, based on the transformation of hydrogen peroxide.
Changes in Malondialdehyde, protein oxidation, super oxide and catalase activities from baseline to 6 months.
Timepoint [1] 6897 0
At baseline, 3 and 6 months

Eligibility
Key inclusion criteria
Type 2 diabetes mellitus subjects without malnutrition or severe complications of the disease (cardiovascular, renal, visual and cerebral), male or female, duration of the disease between 1-10 years, good psychological condition, non-smoker and non-alcoholic. Patient given written consent after provided with sufficient information about participation in the trial.
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant, high blood pressure, psychiatric disorders, severe heart failure or other acutely life-threatened conditions, severe chronic inflammatory disease, less than 40 years old, renal disease, duration of type 2 diabetes greater than 10 years, newly diagnosed persons with type diabetes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a computer generated random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/1998
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
231
Accrual to date
Final
Recruitment outside Australia
Country [1] 915 0
Cuba
State/province [1] 915 0

Funding & Sponsors
Funding source category [1] 3307 0
Hospital
Name [1] 3307 0
University of the West Indies
Country [1] 3307 0
Jamaica
Primary sponsor type
University
Name
University of the West Indies
Address
Mona Campus
7A Gibraltar Hall Road
Kingston 7
Country
Jamaica
Secondary sponsor category [1] 2958 0
Hospital
Name [1] 2958 0
The Hermanos Ameijeiras Hospital and The National Institute of Endocrinology
Address [1] 2958 0
San Lazaro 701
Centro Habana La Habana
Havana
Country [1] 2958 0
Cuba

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5292 0
The Hermanos Ameijeiras Hospital Ethics Committee
Ethics committee address [1] 5292 0
San Lazaro 701
Centro Habana La Habana
Havana
Ethics committee country [1] 5292 0
Cuba
Date submitted for ethics approval [1] 5292 0
Approval date [1] 5292 0
21/09/2000
Ethics approval number [1] 5292 0

Summary
Brief summary
Diabetes mellitus is a worldwide health problem predisposing to markedly increased cardiovascular mortality and morbidity. Lipid abnormalities significantly contribute to the increased risk of cardiovascular disease and other morbidity in diabetics. This study investigated the impact of Hatha yoga and conventional physical training exercise regimens on biochemical, oxidative stress indicators and oxidant status in patients with type 2 diabetes mellitus. The study hypothesis is that Hatha yoga exercise as well as conventional physical training exercise has therapeutic preventative and protective effects on diabetes mellitus by decreasing blood glucose and oxidative stress, and improving antioxidant status.
Trial website
Trial related presentations / publications
Accepted for publication in Biomedical Central (BMC) Complementary and Alternative Medicine
Public notes

Contacts
Principal investigator
Name 28533 0
Address 28533 0
Country 28533 0
Phone 28533 0
Fax 28533 0
Email 28533 0
Contact person for public queries
Name 11690 0
Dr. Donovan McGrowder
Address 11690 0
Department of Pathology
Faculty of Medical Sciences
University of the West Indies
Mona Campus
Gibraltar Hall Road
Kingston 7
Jamaica W.I.
Country 11690 0
Jamaica
Phone 11690 0
1-876-927-1410
Fax 11690 0
1-876-977-1811
Email 11690 0
[email protected]
Contact person for scientific queries
Name 2618 0
Dr. Donovan McGrowder
Address 2618 0
Department of Pathology
Faculty of Medical Sciences
University of the West Indies
Mona Campus
Gibraltar Hall Road
Kingston 7
Jamaica W.I.
Country 2618 0
Jamaica
Phone 2618 0
1-876-927-1410
Fax 2618 0
1-876-977-1811
Email 2618 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEffect of exercise therapy on lipid profile and oxidative stress indicators in patients with type 2 diabetes2008https://doi.org/10.1186/1472-6882-8-21
N.B. These documents automatically identified may not have been verified by the study sponsor.