- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02735564
Change in Reward System Activation and Gut Microbiota Following RYGB and Sleeve Gastrectomy for Weight Loss vs. Control-Heads Up Ancillary
3. januar 2020 opdateret af: Corby K. Martin, Pennington Biomedical Research Center
Change in Reward System Activation and Gut Microbiota Following Roux-en-y and Sleeve Gastrectomy for Weight Loss as Compared to a Control- Heads Up Ancillary
Bariatric surgery is considered an effective long-term intervention for the treatment of obesity and associated complications.
While bariatric surgery has been shown to result in a large sustained weight loss, the degree of weight loss and maintenance thereafter varies greatly.
The Heads Up Surgical Demonstration Project (Heads Up) is a 5 year project examining weight loss after an intensive medical intervention (IMI) and the 2 most widely used bariatric surgeries (roux-en-y gastric bypass or RYGB and sleeve gastrectomy or SG).
Baseline data are collected prior to surgery and follow-up data are collected at 6 months and annually thereafter.
A recent meta-analysis revealed that RYGB resulted in greater weight loss and is more effective in resolving obesity related comorbidities than SG, although SG has been shown to result in a reduction of perioperative complications and reoperations1.
Full elucidation of the mechanisms leading to variation in success for weight loss interventions is crucial to understanding the most effective and reliable treatments for obesity and associated comorbidities.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
6
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70808-4124
- Pennington Biomedical Research Center
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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 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Surgical Groups (RYGB and SG) Inclusion criteria for the two surgery groups (n=16)
- Individuals who qualify for Heads Up and would like to participate in this ancillary study
- Be willing to participate in additional procedures including: 4 brains scans (2 before surgery and 2 after surgery), 2 meal challenges (1 before surgery and 1 after surgery), and 2 microbiota collections (1 before surgery and 1 after surgery).
- Be willing to archive microbiota samples
Control Group:
Inclusion Criteria for the BMI matched control group (n=9):
- Males and females age 21-70 years
- Body Mass Index ≥40 kg/m2 without type 2 diabetes or ≥35 kg/m2 and ≤ 60kg/m² with type 2 diabetes
- Agree to receive frequent contacts from investigators and communicate with program staff for up to 6 months
- Able to give written informed consent
- Able to comply with study procedures
Exclusion Criteria:
Exclusion Criteria for the two surgery groups (n=16):
- Unable or unwilling to give informed consent
- Pregnant or planning on becoming pregnant during the 6 months you participate in the study
- History or presence of unremoveable metal objects (medical or dental) or electronic devices or other contraindication to MRI scanning.
- Unwillingness to complete an MRI due to confined space or other related phobias
Exclusion Criteria for the BMI matched control group (n=9):
- Unable or unwilling to give informed consent
- Hospitalization for psychiatric illness or substance use/abuse within the past year
- Diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, or personality disorder as determined by the medical staff
- Travel plans that do not permit participation
- Pregnant or planning on becoming pregnant during the 6 months you participate in the study
- History of prior bariatric surgery, extensive bowel resection, or hiatal hernia repair (unless approved by the medical staff)
- History of eating disorder such as anorexia nervosa, bulimia, or binge eating (unless approved by program staff)
- Current major depressive episode or history of suicidal behaviors
- Severe congestive heart failure (NYHA class III, IV)
- Second degree or greater heart block
- Other medical, psychiatric, or behavioral limitations that in the judgement of the investigator may interfere with program participation or the ability to follow the intervention protocol
- History or presence of unremoveable metal objects (medical or dental) or electronic devices or other contraindication to MRI scanning.
- Unwillingness to complete an MRI due to confined space or other related phobias
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: RYGB
Bariatric Surgery:Roux-en-y
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Eksperimentel: SG
Bariatric Surgery: Sleeve Gastrectomy
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Placebo komparator: Control
BMI matched control
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neural reward sensitivity
Tidsramme: baseline, 6 months
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Investigate change in reward activation patterns in the brain in response to food cues using fMRI.
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baseline, 6 months
|
|
gut microbiota
Tidsramme: baseline, 6 months
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Determine if gut microbiota, as analyzed via stool sample collection, changes from baseline (prior to surgery) to 6 months follow-up (post-surgery) among the groups.
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baseline, 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Keely Hawkins, Ph.D., Pennington Biomedical Research Center
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 (Faktiske)
1. april 2016
Primær færdiggørelse (Faktiske)
1. november 2017
Studieafslutning (Faktiske)
1. april 2018
Datoer for studieregistrering
Først indsendt
6. april 2016
Først indsendt, der opfyldte QC-kriterier
6. april 2016
Først opslået (Skøn)
12. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PBRC 2015-064
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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 .
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