NCT04318184

Brief Summary

Diabetes is considered an epidemic disease with the 463 million affected patients (between 20-79 years) and it is estimated that 578 million people will have diabetes by 2030 \[1\]. According to The International Diabetes Federation (IDF) reports, 4,2 million adults were considered to die due to diabetes and its complications in 2019. Because of this situation, diabetes treatment is so important. The recommendations for the treatment of DM include medications and lifestyle management, which includes physical activity (PA), medical nutrition therapy, smoking cessation counseling, and psychosocial care. PA is an important aspect of management that directly under the control of the patients. So the investigators want to interrogate the effect of exercise on blood parameters, blood pressure, body compositions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

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

January 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 19, 2020

Last Update Submit

March 20, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

ExerciseType-2 Diabetes Mellitus treatmentBody CompositionBlood SamplesBlood Pressure

Outcome Measures

Primary Outcomes (7)

  • "Change" is being assessed for HbA1c

    Blood parameters

    Baseline and end of the 3rd month

  • "Change" is being assessed Total Cholesterol

    Blood parameters

    Baseline and end of the 3rd month

  • "Change" is being assessed for LDL

    Blood parameters

    Baseline and end of the 3rd month

  • "Change" is being assessed for HDL

    Blood parameters

    Baseline and end of the 3rd month

  • "Change" is being assessed for Blood Glucose

    Blood parameters

    Baseline and end of the 3rd month

  • "Change" is being assessed for Post prandial glucose

    Blood parameters

    Baseline and end of the 3rd month

  • "Change" is being assessed for Triglyceride

    Blood parameters

    Baseline and end of the 3rd month

Secondary Outcomes (4)

  • "Change" is being assessed for Blood Pressure

    Baseline and end of the 3rd month

  • "Change" is being assessed for Fat Mass (kg)

    Baseline and end of the 3rd month

  • "Change" is being assessed for Muscle Mass (kg)

    Baseline and end of the 3rd month

  • "Change" is being assessed for BMI

    Baseline and end of the 3rd month

Study Arms (1)

Exercise

EXPERIMENTAL

Submaximal aerobic exercise protocol

Procedure: Aerobic exercise

Interventions

Aerobic exercisePROCEDURE

The aerobic exercise protocol was performed 3 times a week for 3 months on the treadmill. Loading periods were performed according to the heart rate maximum using the Karvonen formula (%60-80 Heart rate maximum)

Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons who were diagnosed with DM,
  • Aged between 18 and 65 years,
  • Patients who completed the three-month exercise program.

You may not qualify if:

  • Had chronic drug (antidiabetic and antilipidemic) adjustments for 3 months at the beginning and during the exercise program,
  • Participated in an exercise program before,
  • Had a health condition other than DM associated with glucose metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 23, 2020

Study Start

January 2, 2018

Primary Completion

April 5, 2018

Study Completion

December 10, 2019

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)