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CompletedNCT03925519Updated Apr 24, 2019

Exercise as Cardio Protective Modulates in Diabetic Patients

An observational study in Diabetes Mellitus and Exercise, sponsored by King Saud University. Completed. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-24.

Sponsored by King Saud University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
50
Ages
45 Years to 70 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Diabetes Mellitus
  • Exercise

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 50 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

King Saud University is the lead sponsor of 164 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
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 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:

  • 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).
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • OtherSupervised aerobic exercise
06

What researchers measure

Primary outcomes

  1. 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%) .

    Time frame: six months

  2. 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

    Time frame: six months

Secondary outcomes

  1. Analysis of Nitric Oxide

    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

    Time frame: six months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03925519
Lead sponsor
King Saud University
Responsible party
Sami Gabr (clinical Professor, King Saud University) — Principal investigator
First posted
Apr 24, 2019
Start date
Jan 25, 2013
Primary completion
Apr 15, 2014
Completion
May 26, 2014
Last update
Apr 24, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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