Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
210 participants
OBSERVATIONAL
2018-10-01
2028-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgical cohort
Patients with type 2 diabetes undergoing Roux-en-Y gastric bypass surgery
Roux-en-Y gastric bypass (RYGB)
Bariatric surgery
Control
Healthy volunteers with normal body mass index
No interventions assigned to this group
Interventions
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Roux-en-Y gastric bypass (RYGB)
Bariatric surgery
Eligibility Criteria
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Inclusion Criteria
* 18-80 years
* Type 2 diabetes mellitus or prediabetes
* Stable weight for at least 3 months
* Obese (BMI ≥30kg/m2)
* Eligible for surgery on the National Health Service (NHS) under The National Institute for Health and Care Excellence (NICE) 2014 criteria
* Aged 18-80 years
* Male or female
* Body mass index 19 - 25 kg/m2
* Stable weight for at least three months
Exclusion Criteria
* Inability to give informed consent
* Type 1 diabetes
* Low fasting C-peptide
* Secondary diabetes or absence of β-cell function
* Unable to undergo DEXA, cirrhosis, ascites, or other condition that may modify body fat composition e.g. underlying malignancy
* Current smoker
* Participation in another (interventional) trial within the last 3 months
* Unable to understand English
Healthy volunteers
* Abnormal glucose tolerance and fasting glucose
* History of any medical, or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study
* Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study
* Pregnancy or breastfeeding
* Unable to maintain adequate contraception for the duration of the study
* Donated blood during the preceding 3 months or intention to do so before the end of the study
* Current smoker
* Participation in another trial within the last 3 months
* Unable to understand English
18 Years
80 Years
ALL
Yes
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Tricia Tan, MB ChB
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College Healthcare NHS Trust
London, Greater London, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Julia S Kenkre, MB BChir
Role: primary
References
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Kenkre JS, Ahmed AR, Purkayastha S, Malallah K, Bloom S, Blakemore AI, Prevost AT, Tan T. Who will benefit from bariatric surgery for diabetes? A protocol for an observational cohort study. BMJ Open. 2021 Feb 10;11(2):e042355. doi: 10.1136/bmjopen-2020-042355.
Other Identifiers
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IRAS:231300
Identifier Type: -
Identifier Source: org_study_id
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