- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03547063
Responses to Appetite and Taste in the Brain Circuits That Control Eating Behaviour (TASTER)
15 januari 2021 uppdaterad av: University College, London
Responses to Appetite and Taste in the Brain Circuits That Control Eating Behaviour: An fMRI Study Evaluating Brain Structure, Connectivity and Responses to Taste Across Different Body Weight Categories and in Response to Weight Loss
The aim of this study is to gain insight into brain structure and the neural networks that control taste and eating behaviour in patients with severe obesity undergoing a primary sleeve gastrectomy (SG) or a lifestyle intervention for weight loss compared with normal weight individuals, using functional magnetic resonance imaging (fMRI).
Studieöversikt
Status
Upphängd
Betingelser
Detaljerad beskrivning
This is an observational study aiming to gain insight into brain structure and the neural networks that control taste and eating behaviour in patients with severe obesity undergoing a primary sleeve gastrectomy (SG) or a lifestyle intervention for weight loss compared with normal weight individuals using functional magnetic resonance imaging (fMRI).
Drops of liquid foods and a control solution will be delivered to the participants' mouth during fMRI scanning.
Body weight, gut hormones from serial blood samples, appetite scores and taste will be assessed at each study visit.
Studietyp
Observationell
Inskrivning (Förväntat)
75
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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London, Storbritannien, NW1 2BU
- University College London Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Participant groups:
Participants with severe obesity
- SG: 25 participants, male and female, aged 18-50 years, body mass index (BMI) 35-50 kg/m2, due to undergo primary SG.
- Lifestyle intervention: 25 participants, male and female, aged 18-50 years, BMI 35-50 kg/m2.
- Participants with normal weight: 25 participants, aged 18-50 years BMI 18.5-24.9 kg/m2, age and gender matched to group with severe obesity.
Beskrivning
Inclusion Criteria:
- Female and male adults aged 18-50 years.
- Right-handed.
- No MRI contra-indications.
- Weight stable at time of recruitment, defined as less than 5% variation in body weight over the preceding 3 months.
- Proficient in written and spoken English.
- Able to comply with study protocol.
- Willing and able to provide written informed consent.
- Participants must be registered with a general practitioner (GP).
- Willing for their treating consultant or their GP and the study team to be informed in the event of an incidental abnormal finding being detected by the investigations or assessments that form part of this study.
- Able to lie flat for 1 hour.
Group-specific inclusion criteria:
SG group:
- BMI of 35-50 kg/m2
- Planned to undergo primary SG surgery and fulfilling eligibility criteria for bariatric surgery.
Lifestyle intervention group:
- BMI of 35-50 kg/m2
- Willing to undergo a lifestyle intervention programme with a view to achieving approximately 10% weight loss.
Normal weight group:
- BMI 18.5-24.9 kg/m2
Exclusion Criteria:
- Body weight greater than 130kg (due to weight limit of MRI Scanner).
- Contraindications specific to MRI scanning: metallic implants (cardiac pacemakers, aneurysm clips, permanent eye lining, cochlear implants or anyone who has been exposed to metallic flakes or splinters).
- Type 1 and type 2 diabetes (in view of altered circulated gut hormone profiles and gustatory function).
- Menopause (in view of findings that the menopause affects gustatory function).
- Smoking (in view of the fact that smoking affects salivary gut hormones and gustatory function).
- Vitamin B12 or zinc deficiency (in view of deficiencies affecting gustatory function).
- Untreated severe depression.
- Eating disorders including bulimia and self-induced vomiting.
- Neurological or psychiatric conditions.
- Acute illness or chronic conditions that may impact upon gustatory and olfactory function.
- Acute illness or chronic conditions that may impact upon post-operative weight loss.
- Known or suspected history of HIV, Hepatitis B or C or other blood-borne diseases (in view of safety regulations regarding exposure to blood products)
- Pregnancy or lactation.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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Sleeve Gastrectomy (SG)
25 participants, male and female, aged 18-50 years, body mass index (BMI) 35-50 kg/m2, due to undergo primary SG
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Lifestyle Intervention
25 participants, male and female, aged 18-50 years, BMI 35-50 kg/m2
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Normal Weight
25 participants, aged 18-50 years BMI 18.5-24.9
kg/m2, age and gender matched to group with severe obesity
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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BOLD signal change after SG
Tidsram: approximately 6 weeks
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To determine the effect of SG, at 10% weight loss, upon whole-brain neural response to taste, in the fed and fasted state, detected through blood-oxygen-level dependent (BOLD) signal, in patients with severe obesity.
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approximately 6 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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BOLD signal change after lifestyle intervention
Tidsram: average of 12 weeks
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The effect of 10% weight loss in patients with severe obesity induced by a lifestyle intervention on BOLD signal to taste in the fed and fasted state and compared to SG.
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average of 12 weeks
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BOLD signal in response to taste in severe obesity compared to normal weight
Tidsram: baseline
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Brain responses, as BOLD signal, to taste in the fed and fasted state in severe obesity compared to normal weight
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baseline
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BOLD signal change post-SG
Tidsram: 6 months
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Whole brain neural response in BOLD signal to taste, in the fed and fasted state, 6 months following SG versus normal weight
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6 months
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Correlation of taste responses and gut hormones
Tidsram: baseline
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The relationship between the neural correlates of taste and levels of circulating gut hormones in severe obesity compared to normal weight
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baseline
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Correlation of taste responses and gut hormones
Tidsram: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
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The relationship between the neural correlates of taste and levels of circulating gut hormones after 10% weight loss by SG compared to lifestyle intervention
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approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
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Correlation of taste responses and gut hormones
Tidsram: 6 months post-SG compared to baseline
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The relationship between the neural correlates of taste and circulating gut hormone levels
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6 months post-SG compared to baseline
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Correlation of taste responses and gut hormones
Tidsram: 6 months
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The relationship between the neural correlates of taste and levels of circulating gut hormones post-SG compared to normal weight
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6 months
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Brain structure
Tidsram: Baseline
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Comparison of brain structure in severe obesity and normal weight
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Baseline
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Brain structure 6 months following SG
Tidsram: 6 months
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Comparison of brain structure 6 months following SG to baseline
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6 months
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Brain structure after 10% weight loss
Tidsram: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
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Comparison of brain structure following 10% weight loss induced by SG versus lifestyle intervention
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approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Rachel L Batterham, PhD FRCP, UCL
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Makaronidis JM, Neilson S, Cheung WH, Tymoszuk U, Pucci A, Finer N, Doyle J, Hashemi M, Elkalaawy M, Adamo M, Jenkinson A, Batterham RL. Reported appetite, taste and smell changes following Roux-en-Y gastric bypass and sleeve gastrectomy: Effect of gender, type 2 diabetes and relationship to post-operative weight loss. Appetite. 2016 Dec 1;107:93-105. doi: 10.1016/j.appet.2016.07.029. Epub 2016 Jul 22.
- Batterham RL, ffytche DH, Rosenthal JM, Zelaya FO, Barker GJ, Withers DJ, Williams SC. PYY modulation of cortical and hypothalamic brain areas predicts feeding behaviour in humans. Nature. 2007 Nov 1;450(7166):106-9. doi: 10.1038/nature06212. Epub 2007 Oct 14.
- Neseliler S, Han JE, Dagher A. The Use of Functional Magnetic Resonance Imaging in the Study of Appetite and Obesity. In: Harris RBS, editor. Appetite and Food Intake: Central Control. 2nd edition. Boca Raton (FL): CRC Press/Taylor & Francis; 2017. Chapter 6. Available from http://www.ncbi.nlm.nih.gov/books/NBK453146/
- Zhang Y, Ji G, Xu M, Cai W, Zhu Q, Qian L, Zhang YE, Yuan K, Liu J, Li Q, Cui G, Wang H, Zhao Q, Wu K, Fan D, Gold MS, Tian J, Tomasi D, Liu Y, Nie Y, Wang GJ. Recovery of brain structural abnormalities in morbidly obese patients after bariatric surgery. Int J Obes (Lond). 2016 Oct;40(10):1558-1565. doi: 10.1038/ijo.2016.98. Epub 2016 May 20.
- Goldstone AP, Miras AD, Scholtz S, Jackson S, Neff KJ, Penicaud L, Geoghegan J, Chhina N, Durighel G, Bell JD, Meillon S, le Roux CW. Link Between Increased Satiety Gut Hormones and Reduced Food Reward After Gastric Bypass Surgery for Obesity. J Clin Endocrinol Metab. 2016 Feb;101(2):599-609. doi: 10.1210/jc.2015-2665. Epub 2015 Nov 18.
- Faulconbridge LF, Ruparel K, Loughead J, Allison KC, Hesson LA, Fabricatore AN, Rochette A, Ritter S, Hopson RD, Sarwer DB, Williams NN, Geliebter A, Gur RC, Wadden TA. Changes in neural responsivity to highly palatable foods following roux-en-Y gastric bypass, sleeve gastrectomy, or weight stability: An fMRI study. Obesity (Silver Spring). 2016 May;24(5):1054-60. doi: 10.1002/oby.21464.
- Karra E, O'Daly OG, Choudhury AI, Yousseif A, Millership S, Neary MT, Scott WR, Chandarana K, Manning S, Hess ME, Iwakura H, Akamizu T, Millet Q, Gelegen C, Drew ME, Rahman S, Emmanuel JJ, Williams SC, Ruther UU, Bruning JC, Withers DJ, Zelaya FO, Batterham RL. A link between FTO, ghrelin, and impaired brain food-cue responsivity. J Clin Invest. 2013 Aug;123(8):3539-51. doi: 10.1172/JCI44403. Epub 2013 Jul 15.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 december 2018
Primärt slutförande (Förväntat)
1 december 2021
Avslutad studie (Förväntat)
1 december 2022
Studieregistreringsdatum
Först inskickad
11 maj 2018
Först inskickad som uppfyllde QC-kriterierna
23 maj 2018
Första postat (Faktisk)
6 juni 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 januari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 januari 2021
Senast verifierad
1 januari 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 18/0233
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