Exercise as Cardio Protective Modulates in Diabetic Patients

NCT03925519 | Completed

• 1 other identifier: RRC-2013-010
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diabetes Mellitus; Exercise

Outcome Measures

Primary Outcomes (2)

• Estimation of coronary heart disease risk score

  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)

  Blood glucose was measured using a glucose oxidase and peroxidase (GOD-POD) colorimetric method before and after exercise training

  six months

Secondary Outcomes (1)

• Analysis of Nitric Oxide

  six months

Study Arms (2)

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)

Other: Supervised aerobic exercise

Interventions

Supervised aerobic exercise OTHER

obese group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

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.

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical Professor

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 24, 2019
• Study Start: January 25, 2013
• Primary Completion: April 15, 2014
• Study Completion: May 26, 2014
• Last Updated: April 24, 2019

Record last verified: 2019-04