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Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus

20. mars 2020 oppdatert av: Marmara University

First Exercise Reports of Diabetes Centre: Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus

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.

Studieoversikt

Status

Fullført

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

Intervensjonell

Registrering (Faktiske)

88

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Istanbul, Tyrkia
        • Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. januar 2018

Primær fullføring (Faktiske)

5. april 2018

Studiet fullført (Faktiske)

10. desember 2019

Datoer for studieregistrering

Først innsendt

19. mars 2020

Først innsendt som oppfylte QC-kriteriene

20. mars 2020

Først lagt ut (Faktiske)

23. mars 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. mars 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Diabetes mellitus, type 2

Kliniske studier på Aerobic exercise

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