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

February 14, 2025 updated by: Safak Yigit, Istanbul Galata University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Istanbul Galata University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day
Funcitonal capacity
Time Frame: 1 day
Submaximal functional exercise capacity of the participants will be evaluated with the six-minute walk test.
1 day
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.
1 day
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.
1 day
Body fat-muscle ratios
Time Frame: 1 day
Body fat-muscle ratios;These measurements will be determined by bioelectrical impedance.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 week (seven days)
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.
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Galata University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biruni University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Buket Akinci, Assoc.Prof, Biruni University
  • Principal Investigator: Safak Yigit, PhD(c), Istanbul Galata University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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