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
NA
20 participants
INTERVENTIONAL
2020-01-16
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm Study
Total Diet Replacement for 12 weeks, food reintroduction 6 weeks
Total Dietary Replacement
Total Dietary Replacement
Interventions
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Total Dietary Replacement
Total Dietary Replacement
Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 yrs
* T2DM
* Willingness to check daily blood sugars
* HbA1c between 53mmol(7%)- 108 mmol(12%)
* Weight stable for 3 months
* Capacity to consent
Exclusion Criteria
* Untreated thyroid dysfunction (patients who have been euthyroid on medication for at least 3 months can be included)
* Use of medication adversely that affects diabetes control (e.g. steroids/ immunosuppressants/ certain antipsychotics)
* Incapacity to give informed consent
* History of an eating disorder/ purging behaviour
* Previous gastric bypass/ banding
* Use of Leptin Therapy
* Untreated retinopathy
18 Years
99 Years
ALL
No
Sponsors
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Cambridge University Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Mandour Omer Mandour
Wellcome Trust Senior Clinical Fellow
Principal Investigators
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David Savage
Role: PRINCIPAL_INVESTIGATOR
Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge
Locations
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Cambridge University Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Mandour O Mandour, MBBS, MRCP
Role: primary
References
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Lim EL, Hollingsworth KG, Aribisala BS, Chen MJ, Mathers JC, Taylor R. Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetologia. 2011 Oct;54(10):2506-14. doi: 10.1007/s00125-011-2204-7. Epub 2011 Jun 9.
Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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A095183
Identifier Type: -
Identifier Source: org_study_id