- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT03730727
Exercise-meal Timing and Postprandial Glucose Control
Maximizing Postprandial Glycaemic Control: When is the Right Time for Physical Activity
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Healthy volunteers will undergo an informed consent and screening visit to determine their eligibility. Participants who are included will then be assigned to one of the three studies (walking, standing, or circuit-exercises) and then come to the lab on 5 consecutive mornings to undergo a pre-trial visit and 4 experimental trial visits (A, B, C, and D). The order of the experimental trial visits will be randomized in a counter-balanced, cross-over design.
Screening visit: Having read the participant info sheet, a study investigator will discuss the project with the potential participant who will have the chance to ask any questions. Informed consent will be sought and a General Health and Physical Activity Questionnaire will be completed. Body weight, height, resting heart rate, blood pressure, and waist circumference will be measured, and blood measures of glycated hemoglobin, triglycerides, and cholesterol will be taken.
Pre-trials visit: Participants will come to the laboratory to receive an accelerometer physical activity monitor, a continuous glucose monitor, and to complete a physical activity bout (walking, standing, or stair climbing, depending on which study they are enrolled). Over the next 5 consecutive days, participants will be instructed to maintain their normal diet and activity habits, to record their dietary intake, to refrain from vigorous exercise and alcohol, and continue wearing the accelerometer and continuous glucose monitoring devices at all times.
Experimental trial A: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. They will remain in a seated position for 2 hours and then complete the physical activity bout (30-min walk, 30-min stand, or 10-min circuit-exercises) after which they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial B: Following an 8-10 hour overnight fast, participants will come to the lab and complete the physical activity bout. Immediately after this they will be given a 500 calorie meal-replacement drink to consume within 10 minutes and will remain in a seated position for 2 hours, after which they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial C: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. Immediately after finishing the meal they will complete the physical activity bout and then remain in a seated position until 2-hours has passed since ingesting the meal. After this time they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial D: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. Thirty minutes after finishing the meal they will complete the physical activity bout and then remain in a seated position until 2-hours has passed since ingesting the meal. After this time they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
After the final trial, the accelerometer and continuous glucose monitoring devices will be collected and the participant's role in the study will end.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
West Midlands
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Edgbaston, West Midlands, Egyesült Királyság, B15 2TT
- University of Birmingham
-
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Age 18-65 years.
- Body Mass Index 18-30 kg/m2.
- Generally healthy.
Exclusion Criteria:
- Smoking.
- Pregnancy, or planning to become pregnant, or a nursing mother.
- More than 2 kg weight change during the last month.
- Diabetes.
- Evidence of, or being treated for, cancer or infectious/non-infectious chronic hematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal diseases.
- Any contraindication to exercise
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Aktív összehasonlító: Control
A liquid meal replacement shake containing 500 kcal (55% kcals from carb, 30% fat, 15% protein) will be administered at approx.
8 am following an 8-10 hour overnight fast.
Postprandial blood glucose responses will be assessed for 2-hours post-ingestion.
Two-hours after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]).
|
Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).
Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.
|
Kísérleti: Immediate prior to meal
At approx.
8 am following an 8-10 hour overnight fast, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]).
Immediately after completion of this bout, a liquid meal replacement shake containing 500 kcal will be administered.
Postprandial blood glucose responses will be assessed for 2-hours post-ingestion.
|
Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).
Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.
|
Kísérleti: Immediate post-meal
A liquid meal replacement shake containing 500 kcal will be administered at approx.
8 am following an 8-10 hour overnight fast.
Postprandial blood glucose responses will be assessed for 2-hours post-ingestion.
Immediately after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]).
|
Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).
Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.
|
Kísérleti: 30-minutes post-meal
A liquid meal replacement shake containing 500 kcal will be administered at approx.
8 am following an 8-10 hour overnight fast.
Postprandial blood glucose responses will be assessed for 2-hours post-ingestion.
Thirty-minutes after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]).
|
Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).
Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Postprandial blood glucose concentrations.
Időkeret: In all trials, postprandial blood glucose concentrations will be measured - the change from baseline (immediately prior to meal ingestion) 2-hours after meal ingestion.
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Continuous glucose monitoring (CGM; Dexcom G5 Mobile) will be used to measure the change in glucose levels from baseline.
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In all trials, postprandial blood glucose concentrations will be measured - the change from baseline (immediately prior to meal ingestion) 2-hours after meal ingestion.
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Postprandial blood glucose control (mean).
Időkeret: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
|
Mean glucose levels will be derived from CGM-measurements.
|
In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
|
Postprandial blood glucose control (standard deviation).
Időkeret: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
|
The standard deviation of glucose levels will be derived from CGM-measurements.
|
In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
|
Postprandial blood glucose control.
Időkeret: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
|
The mean amplitude of glycemic excursions will be derived from CGM-measurements.
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In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
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Együttműködők és nyomozók
Szponzor
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- ERN_18-0942
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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