- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02601482
Optimization of Interval-training in Patients With Type 2 Diabetes
A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The time spend with high-intensity (fast) walking is considered to be responsible for the improvements seen, whereas the time spend with low-intensity (slow) walking is considered less important.
This study will assess if IW with maintained fast walking time duration but reduced total time duration (i.e. reduced slow walking time duration) is equally effective as IW with a normal time duration.
Subjects with type 2 diabetes will be included in a crossover, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:
- Sixty minutes of rest (CON)
- Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3 minutes of slow walking; IW-60)
- Fourty-five minutes of time-reduced interval walking (repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking; IW-45).
After the interventions subjects will undergo a standardized mixed meal tolerance test with assessment of glycemic control.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Copenhagen, Danmark, 2100
- Center for Physical Activity Research (CFAS)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Type 2 Diabetes Mellitus
- BMI > 25
Exclusion Criteria:
- Pregnancy
- Smoking
- Contraindication to increased levels of physical activity
- Eating disorder
- Insulin dependence
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Control (CON)
No exercise intervention.
|
|
|
Experimentell: Normal Interval Walking (IW-60).
Sixty minutes with repeated cycles of 3 minutes of fast and 3 minutes of slow walking on a treadmill
|
|
|
Experimentell: Time-reduced Interval Walking (IW-45)
Forty-five minutes with repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking on a treadmill
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Glycemic control
Tidsram: Within the first 4 hours after the intervention
|
Glycemic control will be assessed after each intervention.
Subjects will receive a standardized mixed meal tolerance test (MMTT), and blood glucose values will be obtained during the test.
|
Within the first 4 hours after the intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Matsuda insulin sensitivity index
Tidsram: Within the first 4 hours after the intervention
|
From the measurements of glucose and insulin during the MMTT, the Matsuda index of insulin sensitivity will be assessed.
|
Within the first 4 hours after the intervention
|
|
Stumvoll insulin sensitivity index
Tidsram: Within the first 4 hours after the intervention
|
From the measurements of glucose and insulin during the MMTT, the Stumvoll index of insulin sensitivity will be assessed.
|
Within the first 4 hours after the intervention
|
|
Cederholm insulin sensitivity index
Tidsram: Within the first 4 hours after the intervention
|
From the measurements of glucose and insulin during the MMTT, the Cederholm index of insulin sensitivity will be assessed.
|
Within the first 4 hours after the intervention
|
|
HOMA-2 insulin resistance index
Tidsram: Within the first 4 hours after the intervention
|
From the measurements of glucose and insulin during the MMTT, the HOMA-2 index of insulin resistance will be assessed.
|
Within the first 4 hours after the intervention
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-15008542 - 2
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