- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06246435
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
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 |
Intervention / Treatment |
|---|---|
|
Prediabetic group
The prediabetic group (HbA1c ≤ 6.5, n = 25)
|
|
|
T2MD group
(HbA1c ≥ 6.5, n = 25).
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
February 20, 2014
Primary Completion (Actual)
August 30, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
January 12, 2024
First Submitted That Met QC Criteria
January 30, 2024
First Posted (Actual)
February 7, 2024
Study Record Updates
Last Update Posted (Actual)
February 7, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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