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

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

Study Overview

• Status: Completed
• Conditions: Diabetic Dyslipidemia

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Istanbul Galata University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Followed up in the Diabetes Polyclinic, Department of Internal Medicine, Endocrinology and Metabolic Diseases, Istanbul University, Istanbul Faculty of Medicine

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	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.	1 day
Funcitonal capacity	Submaximal functional exercise capacity of the participants will be evaluated with the six-minute walk test.	1 day
Waist circumference	Waist circumference will be measured at belly level with the patient in an upright position during expiration, with both feet bearing equal weight.	1 day
Hip circumference	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.	1 day
Body fat-muscle ratios	Body fat-muscle ratios;These measurements will be determined by bioelectrical impedance.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level (step count)	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.	1 week (seven days)
Glucose profile	Glucose profile, including Hemoglobin A1c (HbA1c) was measured. Additionally, the glucose profile will be assessed after 12 hours of fasting using standard biochemical analysis.	1 day
Glucose profile	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.	1 day
Lipid profile	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.	1 day

Collaborators and Investigators

• Sponsor: Istanbul Galata University
• Collaborators: Biruni University
• Investigators: Study Director: Buket Akinci, Assoc.Prof, Biruni University; Principal Investigator: Safak Yigit, PhD(c), Istanbul Galata University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: GalataUni

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No