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De klinische studie NCT04812314 (LG) voor Obesitas, Metabool syndroom, Metabole Ziekte, Insulineresistentie, Gewichtsverlies, Gewichtstoename is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Universiteit van MichiganExercise Effects on Adipose Tissue Structure and Function (LG)
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De klinische studie NCT04812314 (LG) is een interventioneel studie bij Obesitas, Metabool syndroom, Metabole Ziekte, Insulineresistentie, Gewichtsverlies, Gewichtstoename met de status recruterend. Het doel is om 46 deelnemers te includeren vanaf 1 maart 2021. De studie wordt geleid door de Universiteit van Michigan en de voltooiing is gepland op 1 maart 2030. Laatste update op ClinicalTrials.gov: 29 juni 2025.
Beknopte samenvatting
Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.
Uitgebreide beschrijving
Exercise is among the first line treatments for obesity and obesity-related diseases, yet it is shocking how little is known about how exercise works to improve health. Expanding the knowledge about novel exercise-induced adaptations in fat tissue of obese individuals and furthering the understanding about mechanisms underlying these adaptations could lead to innovative approaches for preventing and treating insulin resistance and obesity-related diseases.
Overall, the researchers believe that exercise training modifies key processes in subcutaneous fat tissue that may contribute to an increase body fat storage capacity (without increasing fat mass). The research team anticipates that exercise will evoke an even more potent adaptive response when fat tissue is dynamically changing in response to alterations in nutritional status (i.e., weight loss and weight regain).
Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests. After the participant completes the study, the study team will help the participant to lose more weight. Total involvement in the study for each participant will likely be about 8-10 months.
Officiële titel
Exercise Effects on Adipose Tissue Structure and Function
Aandoeningen
ObesitasMetabool syndroomMetabole ZiekteInsulineresistentieGewichtsverliesGewichtstoenameAndere studie-ID's
- LG
- HUM00175528
NCT-ID
Startdatum (Werkelijk)
2021-03-01
Laatste update geplaatst
2025-06-29
Verwachte einddatum
2030-03-01
Inschrijving (Geschat)
46
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Primaire doel
Basiswetenschap
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelExercise This exercise prescription represents a common or "conventional" form of physical activity (e.g., moderate/brisk walking). If assigned to this group, participants will perform 45 minutes of moderate intensity continuous steady-state exercise at 70% maximal heart rate (HRmax) to expend 250 calories 4 days per week. | Oefening Participants will complete a moderate intensity continuous exercise 4 days/week. |
ExperimenteelNo exercise Subjects assigned to this group are to remain sedentary (no planned physical exercise) throughout the duration of the study. | Geen oefening Participants will remain sedentary throughout the duration of the study. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Oral Glucose Tolerance Test (OGTT) | A test in which glucose is given and blood samples taken afterward to determine how quickly it is cleared from the blood will be completed at each clinical visit appointment.. | 2 hours |
Adipose Tissue Fibrosis | measured histologically using Sirus Red Staining, quantified using ImageJ software at each clinical visit appointment. | 30 minutes |
Muscle Capillarization | measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment. | 30 minutes |
Adipose Capillarization | measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment. | 30 minutes |
Fat Cell Size | measured histologically using Hematoxylin and eosin (H \& E) staining, quantified using ImageJ software at each clinical visit appointment. | 3 minutes |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Blood Lipid Profile | A panel of blood tests that screens for abnormalities in blood lipids will be measured at each clinical visit appointment. | 15 minutes |
Blood Pressure | The pressure of circulating blood against the walls of blood vessels will be measured at screening and each clinical visit appointment. | 10 minutes |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Age: 18-40
- Body Mass Index: 27-45 kg/m2
- No regularly planned exercise/physical activity for at least 6 months
- Women must have regularly occurring menses and must be premenopausal
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism, or inflammation
- Weight instability ≥ ± 6 pounds in the last 3 months
- Tobacco or e-cigarette users
- Women must not be pregnant or actively lactating
Universiteit van Michigan488 actieve klinische studies om te verkennenVerantwoordelijke instantie
Jeffrey F Horowitz, Hoofdonderzoeker, professor of Movement Science and director of the Substrate Metabolism Laboratory (SML) at the University of Michigan School of Kinesiology
Centraal Contactpersoon
Contact: Suzette Howton, 734-647-9850, [email protected]
1 Studielocaties in 1 landen
Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United States
Jeffrey F Horowitz, Contact, 7346471076, [email protected]
Recruterend