NCT06246435

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
Last Updated

February 7, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 12, 2024

Last Update Submit

January 30, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Assessment of body weight, and height as anthropometric measurements

    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

    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 Outcomes (2)

  • Analysis of diabetic control parameters

    6 month

  • estimation of lipid profile

    6 month

Study Arms (2)

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

Interventions

Prediabetic groupT2MD group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alghadir AH, Gabr SA, Iqbal A. The effects of supervised aerobic training on dyslipidaemia among diabetic older patients. BMC Endocr Disord. 2024 Oct 9;24(1):212. doi: 10.1186/s12902-024-01745-8.

Biospecimen

Retention: SAMPLES WITHOUT DNA

For all participants, standardized physical examination and collection of serum samples were performed at week 0 (before the onset of the training program), 3 months, and after a 6-month program of moderate aerobic training

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical investigator

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 7, 2024

Study Start

February 20, 2014

Primary Completion

August 30, 2014

Study Completion

October 1, 2014

Last Updated

February 7, 2024

Record last verified: 2024-01