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Metabolic Adaptations to Weight Loss With and Without Exercise (WAX)

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Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05806801 (WAX) ist eine interventionsstudie zur Untersuchung von Fettleibigkeit, Stoffwechselkrankheit, Metabolisches Syndrom, Insulinsensitivität, Insulinresistenz, Gewichtsverlust und hat den Status offene rekrutierung. Die Studie startete am 19. Juli 2023 und soll 68 Teilnehmer aufnehmen. Durchgeführt von Universität Michigan ist der Abschluss für 31. Mai 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 8. April 2025 aktualisiert.
Kurzbeschreibung
Study Purpose:

The combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. A deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment/prevention of obesity-related diseases.

Although a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. This is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. We argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained

Study Summary:

10% Weight Loss Phase - Subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). During this, subjects will be randomized into one of two different experimental groups:

  1. Moderate Intensity Continuous Training (MICT) exercise group
  2. No exercise (control) group

Follow-up Phase: After completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise/physical activity behavior. Subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss.

Total involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).

Offizieller Titel

Metabolic Adaptations to Weight Loss With and Without Exercise

Erkrankungen
FettleibigkeitStoffwechselkrankheitMetabolisches SyndromInsulinsensitivitätInsulinresistenzGewichtsverlust
Weitere Studien-IDs
  • WAX
  • HUM00220220
NCT-Nummer
Studienbeginn (tatsächlich)
2023-07-19
Zuletzt aktualisiert
2025-04-08
Studienende (vorauss.)
2028-05-31
Geplante Rekrutierung
68
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Grundlagenforschung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellModerate Intensity Continuous Training (MICT) exercise group
45 minutes of continuous steady-state exercise at 70% maximal heart rate throughout the 10% weight loss phase of the study
MICT Exercise
Subjects randomized into this group will complete a moderate intensity continuous exercise 4 days/week.
ExperimentellNo exercise (Control)
to remain sedentary (no planned physical exercise) throughout the duration of the 10% weight loss phase of the study
No Exercise (Control)
Subjects randomized into this group will remain sedentary throughout the duration of the study.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Insulin sensitivity
a hyperinsulinemic-euglycemic clamp will be used to quantify peripheral insulin sensitivity
2 hours
Fatty acid turnover
stable isotope tracer infusion methods will be used to assess fatty acid turnover
2 hours
Adipose tissue capillarization
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software
30 minutes
Adipose tissue fibrosis
measured histologically using Sirus Red Staining, quantified using ImageJ software
30 minutes
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Body weight change
Change in body weight will be assessed 6 months after completing the 10% weight loss intervention
6 months
Body fat mass
Body fat mass will be measured by Dual Energy X-ray Absorptiometry (DEXA)
30 minutes
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
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • Age: 18-40
  • Body Mass Index: 30-40 kg/m2
  • Weight stable (±3kg for greater than or equal to about 2 months)
  • No regularly planned exercise/physical activity
  • Women must have regularly occurring menses and must be premenopausal

  • EKG abnormalities
  • Evidence/history of cardiovascular disease, diabetes or other metabolic disease
  • Medications known to affect lipid or glucose metabolism
  • Pregnant or lactating
  • Tobacco or e-cigarette use
  • Prior experience of hypersensitivity to insulin, human albumin, and potassium chloride injection.
  • Allergies/hypersensitivity to local anesthetics of the amide type (e.g., lidocaine)
  • History of hyperkalemia or potential for developing hyperkalemia (including but not limited to taking drugs that may induce hyperkalemia such as cardiac glycosides or potassium sparing diuretics)
  • Anti-coagulant medication (e.g., Coumadin, Rivaroxaban) and Lidocaine allergy/sensitivity are exclusion criteria for the biopsy procedure.
Verantwortliche Partei
Jeffrey F Horowitz, Hauptprüfer, Professor of Movement Science and Director of the Substrate Metabolism Laboratory (SML) at the University of Michigan School of Kinesiology
Zentrale Studienkontakte
Kontakt: Suzette M Howton, 734-647-9850, [email protected]
1 Studienstandorte in 1 Ländern

Michigan

University of Michigan, Ann Arbor, Michigan, 48109, United States
Suzette Howton, Kontakt, 7346479850, [email protected]
Jeff F Horowitz, PhD, Hauptprüfer
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