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fMRI and Appetite-Related Hormones Pre and Post Obesity Surgery

10. januar 2014 opdateret af: Dr. Allan Geliebter, New York Obesity and Nutrition Research Center

Functional Brain Imaging and Appetite-Related Hormones Pre and Post Obesity Surgery

The investigators are looking at the differences in appetite and obesity between weight loss participants and patients undergoing bariatric surgery.

Obese persons between the ages of 18 & 65 are eligible to participate in this study, whether or not they intend to undergo bariatric surgery.

Studieoversigt

Detaljeret beskrivelse

Currently, the only effective long term treatment for severe obesity is bariatric surgery.2 Nearly 200,000 procedures are performed each year, with this number increasing rapidly.3 However, the mechanisms of reduced food intake and weight loss after obesity surgery, particularly Rouen-Y gastric bypass (RYGB), are not well understood. This study utilizes functional magnetic resonance imaging (fMRI) and measures of appetite-related gut peptide levels pre and post bariatric surgery to investigate the neurological and hormonal mechanisms involved in initiation and termination of meals.

The general objective is to better understand the physiological changes resulting in weight loss from obesity surgery, particularly Roux-en-Y gastric bypass (RYGB). The main hypothesis is that the differential mechanisms of action in RYGB will alter the signals involved in the initiation and termination of meals, reflected by changes in both peptide hormone levels and regional brain activity in response to foods. The investigators anticipate that the trigger for meal initiation by potent food stimuli will be diminished following RYGB, as indicated by reduced brain activation in areas associated with food reward and motor planning, including the orbitofrontal cortex (OFC). RYGB will be compared to: a. Gastric Banding (GB), representing the restrictive component of surgery, which itself enhances fullness, but in the absence of any rerouting of the gut, should result in fewer changes in gut peptide levels and brain activation; b. Weight Loss (WL) on a formula diet over 3 mo, which represents the weight loss component of surgery; and c. No Treatment (NT), a general control, with no gastric restriction or weight loss. These group comparisons will help parse the contributions of RYGB surgery to weight loss.

The plan is to study clinically severe obese subjects (S's) pre surgery, and at 3 and 18 mo post surgery. The investigators will examine: 1) fMRI brain activation in response to food stimuli and 2) appetite-related gut peptide levels before and following a fixed meal prior to the fMRI. The findings should reveal potential mechanisms associated with the changes in appetite, eating behaviors, and body weight, both during the rapid weight loss phase at 3 mo post surgery as well as when weight typically stabilizes at a nadir at 18 mo post surgery. The investigators plan to enroll 160 patients: 40 with RYGB, 40 GB, 40 WL, and 40 NT (4-arm study). S's will be within the BMI range of 40-50 and matched across groups for BMI, gender (3:1, f:m), and BED status.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10025
        • St. Luke's-Roosevelt Hospital Center

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • BMI range 35-50 kg/m^2

Exclusion Criteria:

  • diabetes,
  • smoking,
  • pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Roux-en-Y Gastric Bypass
30 subjects who plan to undergo Roux-en-Y Gastric Bypass bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
Andre navne:
  • Meal replacement shake is the product Glytrol.
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
Andre navne:
  • Food cue responses
Eksperimentel: Gastric Banding (Lap-band)
30 subjects who plan to undergo Gastric Banding bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
Andre navne:
  • Meal replacement shake is the product Glytrol.
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
Andre navne:
  • Food cue responses
Eksperimentel: Formula Diet Weight Loss
30 subjects who plan to begin a formula diet to lose weight. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before subjects undertake a 12-week weight loss intervention (T1), at the end of the weight loss intervention (T2) and 18 months after they completed the weight loss intervention(T3).
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
Andre navne:
  • Meal replacement shake is the product Glytrol.
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
Andre navne:
  • Food cue responses
Eksperimentel: No Treatment
30 subjects who do not undergo any treatment for weight loss. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed at baseline (T1) and at 3 months (T2) and 18 months (T3) later.
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
Andre navne:
  • Meal replacement shake is the product Glytrol.
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
Andre navne:
  • Food cue responses
Eksperimentel: Sleeve Gastrectomy Surgery
30 subjects who plan to undergo Sleeve Gastrectomy bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
Andre navne:
  • Meal replacement shake is the product Glytrol.
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
Andre navne:
  • Food cue responses

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in brain activation in response to visual and auditory food cues
Tidsramme: 3 mo pre-surgery and 3 and 18 mo post-surgery
Measures of brain brain activation in areas associated with food reward and motor planning, including the orbitofrontal cortex (OFC). Over the course of 40-min fMRI scans, we will compare change in activation from 3 mo pre-surgery to 3 and 18 mo post-surgery, and predict a post-surgical decrease in activation in such regions.
3 mo pre-surgery and 3 and 18 mo post-surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anthropometrics and Body Composition
Tidsramme: 3 mo pre-surgery and 3 and 18 mo post-surgery
Height and weight will be assessed using a stadiometer and digital scale. Sagittal diameter and waist and hip circumferences, as well as maximum supine width, will be measured. Waist circumference will be measured. Air displacement (Bioelectrical impedance analyses) will also be performed to obtain lean and fat mass. Weights, BMI, and body composition will confirm that the four obese groups are similar at baseline and provide estimates of changes in body fat following treatment.
3 mo pre-surgery and 3 and 18 mo post-surgery
Mood Measures
Tidsramme: 3 mo pre-surgery and 3 and 18 mo post-surgery

We will administer relevant psychological instruments to assess Mood:

The Inventory of Depressive Symptomatology-Self Report (IDS-SR)will be assessed at 3mo pre-surgery, 3mo, 6mo and 18mo post surgery.

3 mo pre-surgery and 3 and 18 mo post-surgery
Change in appetite-related gut peptide levels
Tidsramme: 3 mo pre-surgery and 3 and 18 mo post-surgery
We will measure changes in appetite-related gut peptide levels before and following a fixed meal prior to the fMRI. This will be assessed via blood plasma samples taken on 3 occasions: 3 mo pre-surgery, 3 mo post-surgery, and 18 mo post-surgery. At each session, there will be multiple time points: -15, 0, 15, 30, 60, and 90 minutes before/after ingestion of a meal replacement shake.
3 mo pre-surgery and 3 and 18 mo post-surgery
Eating Behavior
Tidsramme: 3 mo pre-surgery and 3 and 18 mo post-surgery
We will administer relevant psychological instruments to assess Eating Behavior:including Eating Disorder Examination (EDE) to diagnose BED; Binge Eating Scale (BES), correlated with BED status; eating-related behavior (DEBQ - Restraint, Emotional, and Externality subscales); and dietary intake (24-Hour Food Recall).
3 mo pre-surgery and 3 and 18 mo post-surgery

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Allan Geliebter, PhD, New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital, Columbia University

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.

Generelle publikationer

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. juli 2010

Primær færdiggørelse (Forventet)

1. juli 2014

Studieafslutning (Forventet)

1. juli 2015

Datoer for studieregistrering

Først indsendt

9. marts 2012

Først indsendt, der opfyldte QC-kriterier

23. april 2012

Først opslået (Skøn)

24. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 09-101

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 Liquid meal responses

3
Abonner