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Bariatric Surgery Outcomes

5. december 2014 opdateret af: University of California, Los Angeles

Bariatric Surgery Outcomes: Quality of Life / Reproductive-Age Women

The UCLA Metabolic and Bariatric Surgery Program (adult program) and the UCLA Fit for Healthy Weight Program (adolescent program) are committed to the care of morbidly obese patients. This study is observational. The investigators plan to evaluate bariatric surgery outcomes using the BAROS National Database and also to evaluate quality of life pre- and post bariatric surgery. In addition, the investigators plan to enroll a subgroup of 10 reproductive-age women to evaluate: 1) pregnancy and offspring health, 2) long-term nutrition, 3) biomarkers/epigenome, and 4) body-composition/bone-density.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  1. National Database: The purpose of the Bariatric Outcomes Longitudinal Database (BOLD) study is to study the mid- and long-term outcomes of bariatric surgeries and to analyze the relationship between these outcomes and 1) patient demographics and comorbidities, 2) clinical and surgical characteristics, and 3) pre-operative, peri-operative, and post-operative care and treatment. The UCLA program will be just one of many institutions that participate in the BOLD study. Participants include other programs and surgeons who have received a Full Approval or Provisional Status designation in the American Society for Bariatric Surgery (ASBS) Bariatric Surgery Center for Excellence program. This study, along with the database itself, is being established, maintained and overseen by East Carolina University in association with the Surgical Review Corporation.
  2. Health Survey: The purpose of evaluating physical and mental health is to document changes that occur following surgery. Standardized surveys will include SF-36, (Bariatric Analysis and Reporting Outcome System), BAROS, and Epworth Sleepiness Scale. Our hypothesis is that bariatric surgery will improve quality of life for the majority of patients.
  3. Reproductive-Age Women:

While the number of bariatric procedures performed has increased to over 200,000 annually, this number represents only a small fraction of those that qualify. The prevalence of extreme obesity is higher in women than in men (7% vs. 3%), and women are disproportionately more likely to undergo bariatric surgery. Nearly 80% of patients undergoing bariatric surgery are female and 35% are less than 40 years of age.

Given the current demographics of metabolic/bariatric surgery and the epidemic of childhood obesity, it is important to evaluate the long-term impact of bariatric surgery on nutrition, pregnancy, offspring health, and bone density. Despite previous concerns, metabolic/bariatric surgery has been demonstrated to improve maternal outcomes and likely improves neonatal outcomes. Interestingly, weight-loss surgery has been demonstrated to reduce the incidence of obesity in offspring by 50%. It is unclear whether improvements in offspring health are related to changes in the uterine environment, the post-natal environment, or the epigenome.

While obesity has been associated with Vitamin D deficiency and hyperparathyroidism, it is not usually associated with the development of osteoporosis. Bariatric surgery can impair calcium absorption and exacerbate vitamin deficiencies. However, the impact of surgery on bone mineral content and density is unclear. This has particular ramifications for young female patients and the risk of osteoporosis long-term.

The purpose is this portion of the study is to evaluate the impact of metabolic/bariatric surgery on reproductive-age women (age 13 to 30) with respect to weight, nutritional status, body composition, biomarker/epigenome profile, markers of atherosclerosis, and bone mineral content/density.

  1. Obstetrical/Offspring Health and Fertility: The purpose of this assessment is to evaluate the impact of surgery on obstetrical complications, offspring health, and fertility. A simple questionnaire will be administered to women of reproductive age.
  2. Biomarkers /Epigenetic Markers: The purpose of collecting specimens (e.g. blood) and analyzing changes in hormones, biologic markers, and epigenetic markers is to help elucidate potential mechanism involved in weight loss.
  3. Imaging: In collaboration with Children's Hospital - Los Angeles, we will coordinate imaging to evaluate body composition, bone density/content, and subclinical markers of atherosclerosis. Imaging studies will include DEXA (dual x-ray absorptiometry) for patients under 300 lbs, low-dose CT-scan for patients under 350 lbs, and ultrasound of the vessels of the neck.

Undersøgelsestype

Observationel

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA
      • Los Angeles, California, Forenede Stater, 90027
        • Children's Hospital - Los Angeles

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients undergoing bariatric surgery.

Beskrivelse

  1. Bariatric Surgery Patient Cohort:

    Inclusion Criteria:

    • Patients undergoing bariatric surgery.

    Exclusion Criteria:

    • None
  2. Reproductive-Age Women Patient Cohort:

Inclusion Criteria:

  • Patients undergoing bariatric surgery.
  • Age 13-30 females.
  • Weight less than 350lbs (to accommodate imaging).

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
Bariatric Surgery Patients
Patients undergoing bariatric surgery.
Bariatric Surgery
Reproductive-Age Women - Bariatric Surgery Patients
This subgroup of patients will include 10 reproductive-age women.
Bariatric Surgery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Quality of Life.
Tidsramme: up to 5-year.
up to 5-year.
Biomarkers, RNA Expression Profile, Epigenetic Markers
Tidsramme: up to 5-year
up to 5-year
Bone density/content and body composition.
Tidsramme: up to 5-year.
up to 5-year.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Daniel DeUgarte, MD, University of California, Los Angeles

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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. marts 2010

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først indsendt

26. januar 2010

Først indsendt, der opfyldte QC-kriterier

26. januar 2010

Først opslået (Skøn)

27. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. december 2014

Sidst verificeret

1. januar 2010

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sygelig fedme

Kliniske forsøg med Bariatric surgery.

Abonner