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Completed

NCT Number: NCT06829576

Examining Health-related Physical Fitness in Individuals With Diabetic Dyslipidemia.

To compare health-related physical fitness parameters in Type 2DM patients with and without dyslipidemia.Cardiometabolic biomarkers glucose and lipid profile will be noted from medical records. Body composition, functional capacity will be assessed with a six-minute walk test, peripheral muscle strength with a dynamometer, and physical activity level with a pedometer.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Galata University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having been diagnosed with Type 2 DM for at least 1 year,
  • Having an HbA1c value between 6.5-11%,
  • Being between the ages of 35-65,
  • Knowing how to read and write Turkish,
  • Having signed the informed consent form

Exclusion criteria

  • Lack of cooperation
  • Patients with peripheral or central serious neurological disorders
  • Patients with uncontrolled hypertension and uncontrolled arrhythmia
  • Pregnant or lactating patients
  • Patients with diabetic ulcers or neuropathy
  • Chronic renal failure (eGFR<30 ml/min)
  • Chronic liver disease (ALT/AST<3X Upper limit of normal)
  • Patients with serious respiratory system disease
  • Patients with cardiac pacemakers
  • History of previous stroke or myocardial infarction
  • Presence of lower and upper extremity orthopedic problems that may prevent the application of clinical tests

Treatment and study plan

Primary outcomes

  1. Muscle strength

    Time frame: 1 day

    M. Quadriceps muscle strength and hand grip strength measurement will be used to evaluate peripheral muscle strength. Hand-held dynamometer will be used to evaluate quadriceps muscle strength and hand grip strength.

  2. Funcitonal capacity

    Time frame: 1 day

    Submaximal functional exercise capacity of the participants will be evaluated with the six-minute walk test.

  3. Waist circumference

    Time frame: 1 day

    Waist circumference will be measured at belly level with the patient in an upright position during expiration, with both feet bearing equal weight.

  4. Hip circumference

    Time frame: 1 day

    Hip circumference will be measured at the level of the greater femoral trochanter, with the patient in an upright position, with both feet bearing equal weight.

  5. Body fat-muscle ratios

    Time frame: 1 day

    Body fat-muscle ratios;These measurements will be determined by bioelectrical impedance.

Secondary outcomes

  1. Physical activity level (step count)

    Time frame: 1 week (seven days)

    Step Count Measurement: Daily step count will be monitored to determine the physical activity level of the participants.Step count will be assessed with a wearable activity monitor, a portable, easy-to-use tool that can measure objectively (pedometer). With its six-axis sensor, the device records the user's physical activity style information in its temporary memory throughout the duration of use. After one week of use, the data recorded with the wearable activity monitor will be taken.

  2. Glucose profile

    Time frame: 1 day

    Glucose profile, including Hemoglobin A1c (HbA1c) was measured. Additionally, the glucose profile will be assessed after 12 hours of fasting using standard biochemical analysis.

  3. Glucose profile

    Time frame: 1 day

    Glucose profile, including fasting blood glucose (FBG), was measured. Additionally, the glucose profile will be assessed after 12 hours of fasting using standard biochemical analysis.

  4. Lipid profile

    Time frame: 1 day

    Lipid profile, including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), and total cholesterol, will be measured after 12 hours of fasting using standard biochemical analysis.

Sponsors and collaborators

Lead sponsor

Istanbul Galata University

Other

Collaborators

  • Biruni University

Registry information

Official study title

Comparative Examination of Health-related Physical Fitness in Individuals With Diabetic Dyslipidemia With Diabetic Individuals Without Dyslipidemia.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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