- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07630025
Concurrent Exercise Training (T2D)
The Impact of Morning Versus Evening Concurrent High-Intensity Interval Training and Resistance Training on Glycemic Control in in Men With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
The goal of this clinical trial is to investigate the influence of morning versus evening concurrent training consisting of high-intensity interval training and resistance training on glycemic control in men with type 2 diabetes mellitus. The main questions it aims to answer are:
• Which time is best for concurrent exercise training in diabetic patients, morning or evening? Researchers will compare morning versus evening concurrent training consisting of HIIT and RT on glycemic control in men with type 2 diabetes mellitus.
Participants will:
- Perform concurrent training consisting of high-intensity interval training and resistance training for 12 weeks
- Visit the clinic before and after the 12-week experimental period for checkups and tests
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- men aged 40-60 years with a diagnosis of T2D
- HbA1c levels between 7.0% and 9.0%
- treatment with oral hypoglycemic agents for at least 6 months
- a BMI <30 kg/m²
- a physically inactive
Exclusion Criteria:
- current insulin therapy
- a cardiovascular event within the previous 6 months
- cardiovascular, respiratory or musculoskeletal conditions that could limit participation in exercise training
- body weight instability
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Morning concurrent training (amCT)
will perform combined HIIT and RT between 06:00 and 09:00
|
Morning concurrent high-intensity interval training and resistance training
|
|
Eksperimentel: Evening concurrent training (pmCT)
will perform combined HIIT and RT between 16:00 and 19:00
|
evening concurrent high-intensity interval training and resistance training between 16:00 and 19:00
|
|
Ingen indgriben: The control group (CON)
no exercise program
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
glycemic control
Tidsramme: baseline and at 12 weeks.
|
HbA1c
|
baseline and at 12 weeks.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
lipid profile
Tidsramme: baseline and at 12 weeks
|
total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides
|
baseline and at 12 weeks
|
|
cardiorespiratory fitness
Tidsramme: at baseline and at 12 weeks
|
VO2peak
|
at baseline and at 12 weeks
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CT 2026
- 2025/03/33413 (Andet bevillings-/finansieringsnummer: Prince Sattam bin Abdulaziz University)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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