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

NCT06829576 | Completed

• 1 other identifier: GalataUni
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Dyslipidemia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Physical activity level (step count)

  1 week (seven days)

• Glucose profile

  1 day

• Glucose profile

  1 day

• Lipid profile

  1 day

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Galata University: lead
• Biruni University: collaborator

Study Sites (1)

Istanbul Galata University

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Buket Akinci, Assoc.Prof

  Biruni University

  STUDY DIRECTOR

• Safak Yigit, PhD(c)

  Istanbul Galata University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD(c)

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 17, 2025
• Study Start: June 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: December 30, 2022
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)