- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02088190
Effect of Aging on Bariatric Surgery-induced Changes in Metabolism and Cognition
21. juni 2022 opdateret af: Ohio State University
The investigators hypothesize that the improvements in insulin sensitivity, beta (β)-cell function, and inflammation will be greater, and the improvement in sarcopenic obesity will be less, in younger versus older individuals after substantial weight loss induced by sleeve gastrectomy bariatric surgery.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
With an aging population that is increasingly susceptible to obesity and obesity-related comorbidities including sarcopenia and diabetes, effective and safe treatment options tailored to the needs of older adults are imperative.
While medication and lifestyle interventions generally fail to achieve sustained large-scale weight loss, bariatric surgery is the most effective long-term weight loss treatment for obese patients and improves many of the medical complications associated with obesity.
Sleeve gastrectomy (SG) results in substantial weight loss and may be more appropriate for older adults due to its low rate of complications and mortality.
Therefore, SG has been proposed as a reasonable primary treatment modality in older obese individuals, with a substantial recent increase in the number of interventions performed.
Despite the potential benefits, very little is known of the physiologic and metabolic effects of bariatric surgery, including SG, on glucose homeostasis and muscle physiology in older adults.
A fundamental understanding of the effects of excess adiposity and weight loss interventions is of profound importance, especially with emerging evidence that earlier treatment of obesity may delay/prevent many comorbidities.
An underlying inflammatory state has been implicated in the pathogenesis of sarcopenia and insulin resistance and may provide an important connection to the age-related declines seen in older obese patients.
Therefore, this study aims to evaluate the modifying effect of age and inflammation on the SG-induced changes in body composition, muscle physiology, and insulin sensitivity.
This protocol will be conducted in two age cohorts (greater than 60 and less than 50 years old).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
11
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients scheduled to undergo laparoscopic sleeve gastrectomy (SG) at The Ohio State University (OSU) Wexner Medical Center will be divided into two cohorts: 1).
Greater than or equal to 60 years of age and 2).
Less than 60 years of age.
Beskrivelse
Inclusion Criteria:
- Age 21-80 yrs old
- BMI ≥ 35 kg/m2
- Undergoing laparoscopic sleeve gastrectomy (SG)
Exclusion Criteria:
- Smokers
- Presence of diabetes mellitus
- Taking any medication that might affect metabolism
- Severe organ dysfunction
- Pregnant or breastfeeding
- Prior gastrointestinal surgery that might affect study results
- Unable or unwilling to follow the study protocol or any reason the research team believes the subject is not an appropriate candidate for this study
- Weight >450 pounds (Will be unable to fit on the DXA scanner)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Age group 1
Age > 60 years old
|
Type of bariatric surgery
|
|
Age group 2
Age < 60 years old
|
Type of bariatric surgery
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Insulin Sensitivity
Tidsramme: Change from baseline in Insulin sensitivity at 15% weight loss (up to 4 months after surgery)
|
Subjects will undergo a clamp procedure to assess insulin sensitivity at baseline and 15% weight loss after surgery
|
Change from baseline in Insulin sensitivity at 15% weight loss (up to 4 months after surgery)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Beta cell function
Tidsramme: Change from baseline to 15% weight loss (up to 4 months after surgery)
|
Subjects will undergo a mixed meal tolerance test at baseline and 15% weight loss
|
Change from baseline to 15% weight loss (up to 4 months after surgery)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: David P Bradley, MD, Ohio State University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2014
Primær færdiggørelse (Faktiske)
1. november 2018
Studieafslutning (Faktiske)
1. juli 2021
Datoer for studieregistrering
Først indsendt
11. marts 2014
Først indsendt, der opfyldte QC-kriterier
12. marts 2014
Først opslået (Skøn)
14. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juni 2022
Sidst verificeret
1. juni 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ENDO-235
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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