- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04318184
Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus
First Exercise Reports of Diabetes Centre: Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The data of the participants who came to the sports center where is prepared for the diabetes patients in the hospital will be collected from the past registration files on the electronic system.
Sociodemographic data, blood values and bio-impedance measurements of each patient are collected coming to the sports center, routinely.
Patients who had missing data, patients who did not complete the 3-month exercise program were excluded from the analysis. All analyses were performed using the Statistical Package for the Social Sciences (SPSS) version 22. 0 for Windows. Data are expressed as mean ± standard deviation. The one-sample Kolmogorov-Smirnov test was performed to assess the distribution of data. Due to their distribution, numerical variables in different subjects were compared with the t-test or Mann-Whitney U test. Comparison of variables before and after the exercise program were compared by the paired t-test (parametric variable) or Wilcoxon test (non-parametric variable). Probability values were two-tailed, and a p-value of less than 0.05 was considered as significant.
All assessments were performed in the clinic at baseline and end of the 3rd month. The blood samples were collected. The systolic and diastolic blood pressure (SBP and DBP) were measured with an automatic arm BP monitor before and after every session. Body mass and body composition, including percent body fat, fat and fat-free mass, were determined using a bioelectric impedance system with the electrodes in contact with soles and heels of both feet. At the baseline and end of the third month, the same person repeated all assessments.
Patients had recruited 3 sessions a week for 3 months (Monday/Wednesday/Friday). Every session consisted of aerobic exercise protocol and warm-up, cooldown period. Patients aerobic loading capacity was calculated before the every session using by Karvonen formula as submaximal loading.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Istanbul, Tyrkia
- Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Persons who were diagnosed with DM,
- Aged between 18 and 65 years,
- Patients who completed the three-month exercise program.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Exercise
Submaximal aerobic exercise protocol
|
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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
"Change" is being assessed for HbA1c
Tidsramme: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed Total Cholesterol
Tidsramme: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed for LDL
Tidsramme: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed for HDL
Tidsramme: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed for Blood Glucose
Tidsramme: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed for Post prandial glucose
Tidsramme: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed for Triglyceride
Tidsramme: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
"Change" is being assessed for Blood Pressure
Tidsramme: Baseline and end of the 3rd month
|
Sistolic and Diastolic Pressure
|
Baseline and end of the 3rd month
|
"Change" is being assessed for Fat Mass (kg)
Tidsramme: Baseline and end of the 3rd month
|
Evaluation with bio-empedans device (TANITA)
|
Baseline and end of the 3rd month
|
"Change" is being assessed for Muscle Mass (kg)
Tidsramme: Baseline and end of the 3rd month
|
Evaluation with bio-empedans device (TANITA)
|
Baseline and end of the 3rd month
|
"Change" is being assessed for BMI
Tidsramme: Baseline and end of the 3rd month
|
Evaluation with bio-empedans device (TANITA)
|
Baseline and end of the 3rd month
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 17073117-050.06
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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