Exercise as Cardio Protective Modulates in Diabetic Patients

Completed

• Conditions: Exercise; Diabetes Mellitus
• Interventions: Other: Supervised aerobic exercise

• Registration Number: NCT03925519
• Lead Sponsor: King Saud University

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

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 Timeline

• Study Start: 2013-01-25
• Primary Completion: 2014-04-15
• Study Completion: 2014-05-26
• Status Verified: 2019-04
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-22
• Last Update Submitted: 2019-04-22
• Study First Posted: 2019-04-24
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obese group	Supervised aerobic exercise	obese diabetic group (n= 25, BMI ≥ 30 kg/m2)

Primary Outcome Measures

Name	Time	Method
Estimation of coronary heart disease risk score	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%) .
Analysis of blood sugar, glycated hemoglobin (HbA1c)	six months	Blood glucose was measured using a glucose oxidase and peroxidase (GOD-POD) colorimetric method before and after exercise training

Secondary Outcome Measures

Name	Time	Method
Analysis of Nitric Oxide	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