The Effects of Supervised Aerobic Training on Dyslipidemia Among Diabetic Older Patients (T2MD)

January 30, 2024 updated by: Sami Gabr, King Saud University
In this study, we are trying to explore the potential effects of moderate aerobic exercise for six months on the severity values of blood sugar, HbA1c, insulin, lipid profile, and highly sensitive CRP (hs-CRP) in a total of 50 subjects diagnosed with diabetes for more than five years with an age range of 30-70 years.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study explored the influence of 6 months of moderate-intensity supervised aerobic training on diabetic control parameters, serum lipid profile, hs-CRP, and variable-related correlations in prediabetic and type 2 diabetic patients (T2MD). The patients were classified into two groups: the prediabetes group (HbA1c ≤ 6.5, n = 25) and the T2MD group (HbA1c ≥ 6.5, n = 25). The values of blood sugar, HbA1c, insulin, lipid profile, and highly sensitive CRP (hs-CRP) were measured in all subjects by using colorimetric and immunoassay techniques respectively at baseline and postintervention of moderate aerobic exercise for six months. Participants performed the exercise test three times per week for 6 months. The training set comprised of a warming phase by stretching exercises and walking for 5 to 10 minutes, the participants were allowed to reach their precalculated training heart rate (THR) in bout form with a total time of 45 to 60 minutes performed as circuit training using a treadmill, bicycle, and stair master. All patient groups were subjected to estimate diabetic control parameters such as FBS, FI, HbA1c, serum lipid profile, hs-CRP, and BMI as anthropometric changes before and after moderate aerobic exercise training for six month

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.
50

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

No

Sampling Method

Probability Sample

Study Population

Fifty participants aged 30-70 years diagnosed with type 2 diabetes (DM2) for more than 5 years according to the American Diabetes Association criteria were invited to this study. Based on ADA criteria, the subjects were classified according to the level of glycated hemoglobin (HbA1c) into two groups; the prediabetic group (HbA1c ≤ 6.5, n=25) and the diabetic group (HbA1c ≥ 6.5, n=25).

Description

Inclusion Criteria:

diagnosed with type 2 diabetes (DM2) for more than 5 years according to the American Diabetes Association criteria

Exclusion Criteria:

  • Patients with a history of smoking, abnormal alcohol intake, anemia, overt complications of diabetes like nephropathy, neuropathy, retinopathy, and other heart complications, and are suffering from viral infections, chronic liver disease, hypothyroidism, and drugs (diuretics; oral contraceptives) were excluded from this study

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Prediabetic group
The prediabetic group (HbA1c ≤ 6.5, n = 25)
Other: moderate aerobic exercise
T2MD group
(HbA1c ≥ 6.5, n = 25).
Other: moderate aerobic exercise

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
Assessment of body weight, and height as anthropometric measurements
Time Frame: 6 month
In this test we are trying to explorer the effects of exercise training on anthropometric parameter's. Thus, weight, and height, and standardized measurements of weight and height were taken in light clothing without shoes for all patient groups
6 month
Assessment of body mass index ( BMI in kg/m^2)as anthropometric measurements
Time Frame: 6 month
In this test, BMI from body weight and height measurements for each participant were estimated before and after exercise training interventions by using a bioelectrical impedance analysis (BIA) based body composition analyzer (TBF 105, Tanita Corporation, Tokyo, Japan)
6 month

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
Analysis of diabetic control parameters
Time Frame: 6 month
the levels of HbA1c and insulin of the participants were estimated before and after the exercise test.
6 month
estimation of lipid profile
Time Frame: 6 month
lipid profile like total cholesterol, triglycerides, HDL-Cholesterol, and LDL-Cholesterol were estimated in the serum of each participant
6 month

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.
King Saud 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.
February 20, 2014

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.
August 30, 2014

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.
October 1, 2014

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 12, 2024

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.
January 30, 2024

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.
February 7, 2024

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.
February 7, 2024

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.
January 30, 2024

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.
January 1, 2024

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.
  • RRC-2014-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device 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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