Status:

COMPLETED

Weight Off-loading Training, Cardiovascular Indices, Diabetes

Lead Sponsor:

Umm Al-Qura University

Conditions:

Cardiovascular Disease, Diabetes Mellitus Type 2

Peripheral Vascular Disorder Due to Diabetes Mellitus

Eligibility:

All Genders

60-70 years

Phase:

NA

Brief Summary

Aims: To evaluate the effectiveness of partial weight-bearing during aerobic exercise training on cardiovascular disease risk and peripheral vascular function in patients with type 2 diabetes mellitus...

Detailed Description

Diabetes mellitus (DM) continues as a global alarming epidemic, with an increasingly growing health burden and complications across all socioeconomic levels. Type 2 diabetes mellitus (T2DM) is associa...

Eligibility Criteria

Inclusion

  • Type 2 diabetes mellitus patients with 0.6\< ankle brachial index ≤ 0.9, treated only with oral hypoglycemic medications (Biguanide or Sulfonylureas + Biguanide), oral anti-diabetic drugs combination, with stable pharmacological treatment for at least 3 months before the study.
  • Cognitively competent patients, able to walk independently with or without walking aids, assuming a Sedentary lifestyle (less than 30 minutes daily activity) during the last 6 months.
  • Type 2 diabetes mellitus for more than 10 years, with glycosylated hemoglobin (HbA1c% %) level more than 7%, and fasting glucose level more than 7.0 mmol/L.
  • Age range from 60 to 70 years, with normal/ accepted nutritional status (Mini Nutritional Assessment score more than 11).

Exclusion

  • The following condition resulted in the exclusion of the patients from the study at the initial screening stage:
  • Patients with Type 1 diabetes, younger than 60 or older than 70 years.
  • Participation in any previous training program or diet regimen within the last 6 months.
  • Patients with disturbed nutritional status (Mini Nutritional Assessment score less than 11).
  • Serious musculoskeletal or cardiopulmonary disorders that can affect patient safety or the study results.

Key Trial Info

Start Date :

August 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2025

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT06974422

Start Date

August 1 2024

End Date

May 1 2025

Last Update

May 15 2025

Active Locations (1)

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Umm Al-Qura University

Mecca, Saudi Arabia