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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Exercise as Cardio Protective Modulates in Diabetic Patients

Clinicaltrials.gov identifier NCT03925519

Recruitment Status Completed

First Posted April 24, 2019

Last update posted April 24, 2019

Study Description

Brief summary:

- 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

  • Condition or Disease:Diabetes Mellitus
  • Intervention/Treatment: Other: Supervised aerobic exercise
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 50 participants
  • Observational Model: Other
  • Time Perspective: Retrospective
  • Official Title: Supervised Aerobic Exercise as Anti-adiposity and Cardioprotective Modulates in Patients With Type 2 Diabetes Mellitus
  • Actual Study Start Date: January 2013
  • Actual Primary Completion Date: April 2014
  • Actual Study Completion Date: May 2014
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: obese group
obese diabetic group (n= 25, BMI ≥ 30 kg/m2)
Other: Supervised aerobic exercise
Outcome Measures
  • Primary Outcome Measures: 1. 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%) .
  • 2. 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
  • Secondary Outcome Measures: 1. 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
  • Biospecimen Retention: Samples Without DNA

    Blood samples were obtained from all subjects at 0800 h after an overnight fast before and after the training program Venous blood samples (5 mL) were collected into plain tubes, the samples were allowed to clot for half an hour following which samples were centrifuged for 15 minutes at 2000 rpm. Samples were given a coded study identification number and were stored frozen at 80°C until analysis.

Eligibility Criteria
  • Ages Eligible for Study: 45 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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).

Inclusion Criteria:

- patients with type 2 diabetes for more than 5 years.

- Patients who were diagnosed according to the criteria of the American diabetes

- 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).

Contacts and Locations
Sponsors and Collaborators

King Saud University

More Information
  • Responsible Party: King Saud University
  • ClinicalTrials.gov Identifier: NCT03925519 History of Changes
  • Other Study ID Numbers: RRC-2013-010
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 24, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Diabetes Mellitus