- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Istanbul, Turquie
- Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Exercise
Submaximal aerobic exercise protocol
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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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
"Change" is being assessed for HbA1c
Délai: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed Total Cholesterol
Délai: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed for LDL
Délai: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed for HDL
Délai: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed for Blood Glucose
Délai: Baseline and end of the 3rd month
|
Blood parameters
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Baseline and end of the 3rd month
|
"Change" is being assessed for Post prandial glucose
Délai: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
"Change" is being assessed for Triglyceride
Délai: Baseline and end of the 3rd month
|
Blood parameters
|
Baseline and end of the 3rd month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
"Change" is being assessed for Blood Pressure
Délai: 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)
Délai: 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)
Délai: 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
Délai: Baseline and end of the 3rd month
|
Evaluation with bio-empedans device (TANITA)
|
Baseline and end of the 3rd month
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 17073117-050.06
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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