- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05005039
Bone Marrow Fat and Bariatric Surgery-Mediated Bone Loss (ADIMOS-OB)
Results are inconsistent and further studies are needed to better understand the impact of bariatric surgery on the bone-BMA relationship depending on the type of bariatric surgery: RYGB vs. SG. Future studies are also needed to define the molecular mediators of bone loss and BMA changes. Several molecular mediators have been considered including gut hormones, adipokines, gonadal hormones and more recently G-CSF. However, the evidence to support any of these alone or in combination as primary mechanisms of bone loss is scant.
The study will be to explore potential changes in BMA after bariatric surgery and search for possible associated factors. Specifically, we want to investigate if such changes in BMFF differed in participants among different surgical types (RYGB vs. SG) and diabetic status. Secondly, we want to explore factors associated with BMFF changes including metabolic homeostasis (glycemic control and blood lipid levels), adipokines (leptin and adiponectin), calciotropic hormones (Ca++, PTH…), body composition parameters and bone markers (cross-laps, P1NP and sclerostin). We hypothesize that the BMFF would particularly decrease after RYGB compared to SG and that participants with T2D would have a larger decrease in BMFF than participants without T2D.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Julien PACCOU, MD,PhD
- Telefonnummer: +33 0320445962
- E-mail: julien.paccou@chru-lille.fr
Studiesteder
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Lille, Frankrig
- Rekruttering
- Hôpital Roger Salengro, CHU Lille
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Postmenopausal women (defined as last menses >12 months)
- Obesity with a BMI ≥ 35 kg/m²,
- Patients with an indication for bariatric surgery with two surgical techniques, RYGB and SG, but who have never had a bariatric surgery procedure previously,
- Enrollment will be stratified for each surgical techniques, RYGB and SG, by preoperative diabetes status, defined by having HbA1c >6.5% or a prior physician's diagnosis of diabetes plus use of an antidiabetic medication.
- Patients who have signed the informed consent.
Exclusion Criteria:
- women who were pre- and perimenopausal and men in order to minimize sex hormone and BMA changes unrelated to the surgical procedure.
- women who used medications known to impact bone metabolism or BMA, including bisphosphonates, teriparatide, denosumab, hormone replacement therapy (HRT) and oral glucocorticoids (>5mg prednisone equivalent daily for>10 days in the last 3 months.
- Other exclusion criteria included prior bariatric surgery, estimated glomerular filtration rate <30 mL/min,
- any contraindication to magnetic resonance imagery (MRI).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Obese postmenopausal women who will undergo RYGB
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Obese postmenopausal women who will undergo SG
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Variation in bone marrow fat fraction (BMFF) in %
Tidsramme: 12 months
|
12 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Julien Paccou, MD,PhD, University Hospital, Lille
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Andre undersøgelses-id-numre
- 2021_0045
- 2021-A01440-41 (Anden identifikator: ID-RCB number, ANSM)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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Kliniske forsøg med Bariatric Surgery in Postmenopausal Women
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Odense University HospitalRekrutteringAdipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric SurgeryDanmark
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Northwestern UniversityNational Cancer Institute (NCI); Pfizer; University of California, San Francisco og andre samarbejdspartnereRekrutteringPostmenopausal | Duktalt brystkarcinom in situForenede Stater
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)Trukket tilbageStadie 0 Brystkræft | Invasivt brystkarcinom | Stadie IA brystkræft | HER2/Neu negativ | PostmenopausalForenede Stater
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)AfsluttetInvasivt brystkarcinom | Stadie IA brystkræft | Stadie IB brystkræft | Stadie IIA brystkræft | Stadie IIB brystkræft | Østrogenreceptor negativ | Østrogenreceptor positiv | Lobulært brystkarcinom | Postmenopausal | Duktalt brystkarcinom | Duktalt brystkarcinom in situForenede Stater