- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925519
Exercise as Cardio Protective Modulates in Diabetic Patients
April 22, 2019 updated by: Sami Gabr, King Saud University
Supervised Aerobic Exercise as Anti-adiposity and Cardioprotective Modulates in Patients With Type 2 Diabetes Mellitus
- Physical exercise for 6 months produced significant improvement in adiponectin, hs-CRP, and nitric oxide (NO) and was significantly correlated with adiposity markers, lipid profile and glycemic control factors in both obese and non-obese diabetic patients.
- Patients with good physical activity reported a significant decrease in BMI, CHD risk scores, reduced hs-CRP, an increase in the levels of adiponectin and nitric oxide.
- In patients with type 2 diabetes mellitus, adiposity markers, lipid profile, hs-CRP, and adiponectin were significantly improved following moderate exercise interventions
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To elucidate the potential role of exercise as anti-adiposity and anti-cardio protective modulates, we thought to investigate the effect of supervised aerobic training of moderate intensity on adiposity markers, nitric oxide level, plasma adiponectin, hs-CRP, and its association with CHD risk score in obese and non-obese patients with type 2 diabetes.
Study Type
Observational
Enrollment (Actual)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Fifty subjects diagnosed with type 2 diabetes for more than 5 years aged 45-70 years were invited in the period from 2013 to 2014 to participate in this study.
Patients were diagnosed according to the criteria of American diabetes association.32 Based on the values of BMI, the patients were classified into two groups, obese diabetic group (n= 25, BMI ≥ 30 kg/m2) and non-obese group (n= 25, BMI ≤ 30 kg/m2).
Description
Inclusion Criteria:
- patients with type 2 diabetes for more than 5 years.
- Patients who were diagnosed according to the criteria of the American diabetes association.
- Not receiving any drugs affecting the data obtained
- had Normal daily diets
- Not participating in any other exercise programs
- Without any musculoskeletal disorders affecting an exercise program
Exclusion Criteria:
- Exclusion criteria included anemia, overt complications of diabetes like nephropathy, neuropathy, retinopathy, obvious ischemic heart disease (angina, myocardial infarction, and lead electrocardiogram abnormalities), HCV, HBV, chronic liver and kidney diseases, hypothyroidism, and drugs (diuretics; oral contraceptives).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
non-obese
non-obese diabetic patients (n= 25, BMI ≤ 30 kg/m2) were subjected to supervised aerobic exercise
|
|
obese group
obese diabetic group (n= 25, BMI ≥ 30 kg/m2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimation of coronary heart disease risk score
Time Frame: six months
|
The incidence risk score of coronary heart disease among type 2 diabetic participants .patients
were classified into T2DM patients with high CHD risk (UKPDS risk ; ≥ 20%), moderate CHD risk (UKPDS risk ; 10-20%), and low (UKPDS risk;< 10%) .
|
six months
|
Analysis of blood sugar, glycated hemoglobin (HbA1c)
Time Frame: six months
|
Blood glucose was measured using a glucose oxidase and peroxidase (GOD-POD) colorimetric method before and after exercise training
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of Nitric Oxide
Time Frame: six months
|
Plasma NO concentration was estimated as nitrate and nitrite using High Performance Liquid Chromatography technology (HPLC).
Patients were subjected for nitri oxide analysis before and after exercise training interventions
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2013
Primary Completion (Actual)
April 15, 2014
Study Completion (Actual)
May 26, 2014
Study Registration Dates
First Submitted
April 17, 2019
First Submitted That Met QC Criteria
April 22, 2019
First Posted (Actual)
April 24, 2019
Study Record Updates
Last Update Posted (Actual)
April 24, 2019
Last Update Submitted That Met QC Criteria
April 22, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRC-2013-010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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