Diabetes Mellitus, Type 2NCT03842475
Who Will Benefit From Bariatric Surgery for Diabetes?
An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial summary
A study investigating the influence of fat distribution, genetic susceptibility markers for type 2 diabetes (T2DM) and fat distribution, epigenetic and transcriptomic changes and gut hormone responses to a mixed meal on diabetes remission following bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Roux-en-Y gastric bypass (RYGB)
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 5 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 150 patients recruited to completion from Imperial Weight Centre. Up to 60 healthy volunteers
Who may be able to join
- Males and females planning to undergo RYGB
- 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
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- Aged 18-80 years
- Male or female
- Body mass index 19 - 25 kg/m2
- Stable weight for at least three months
Who cannot join
- Current pregnancy
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, Greater London, W12 0HS
Julia S Kenkre, MB BChir
Tricia Tan, MB ChB
About this study
Official title: Who Will Benefit From Bariatric Surgery for Diabetes? Using Fat Distribution Measurement, Gut Hormone Profiles and Genetic Data to Predict Diabetes Remission
A study investigating the influence of fat distribution, genetic susceptibility markers for type 2 diabetes (T2DM) and fat distribution, epigenetic and transcriptomic changes and gut hormone responses to a mixed meal on diabetes remission following bariatric surgery.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Roux-en-Y gastric bypass (RYGB)
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypass (RYGB)Procedure or surgery
Bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgical cohort | Patients with type 2 diabetes undergoing Roux-en-Y gastric bypass surgery Receives: Procedure: Roux-en-Y gastric bypass (RYGB) | |
| Control | Healthy volunteers with normal body mass index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes remission (partial or complete)
Measured: 1 year
Diabetes remission (complete)
Measured: 1 year
Secondary outcomes (6)
Waist circumference, waist/hip ratio (cm)
Measured: 1 year
Body mass index (kg/m2)
Measured: 1 year
Weight loss
Measured: 1 year
Change in visceral adipose tissue
Dual Energy Xray Absorptiometry measurement (DEXA)
Measured: 1 year
Change in visceral adipose tissue
Magnetic resonance imaging (MRI) measurement
Measured: 1 year
Change in ectopic fat
MRI measurement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Oct 2018
- Primary completion1 Jan 2025 (estimated)
- Study completion5 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Tricia Tan, MB ChB, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842475
- Sponsor's protocol ID
- IRAS:231300
- Status last verified
- Apr 2023
- First submitted
- 31 Jan 2019
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33568372
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Who Will Benefit From Bariatric Surgery for Diabetes? Using Fat Distribution Measurement, Gut Hormone Profiles and Genetic Data to Predict Diabetes Remission
- ClinicalTrials.gov ID
- NCT03842475
- Acronym / sponsor ID
- IRAS:231300
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 5 Oct 2028 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study investigating the influence of fat distribution, genetic susceptibility markers for type 2 diabetes (T2DM) and fat distribution, epigenetic and transcriptomic changes and gut hormone responses to a mixed meal on diabetes remission following bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical cohort | – | Procedure: Roux-en-Y gastric bypass (RYGB)Patients with type 2 diabetes undergoing Roux-en-Y gastric bypass surgery |
| Control | – | –Healthy volunteers with normal body mass index |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 150 patients recruited to completion from Imperial Weight Centre. Up to 60 healthy volunteers
Key inclusion criteria (10 listed)
- Males and females planning to undergo RYGB
- 18-80 years
- Type 2 diabetes mellitus or prediabetes
- Stable weight for at least 3 months
- Obese (BMI ≥30kg/m2)
Key exclusion criteria (19 listed)
- Current pregnancy
- Inability to give informed consent
- Type 1 diabetes
- Low fasting C-peptide
- Secondary diabetes or absence of β-cell function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric bypass (RYGB)Bariatric surgery | Procedure or surgery | Surgical cohort |
Primary outcome
Diabetes remission (partial or complete)
Time frame: 1 year
Diabetes remission (complete)
Time frame: 1 year
6 secondary outcomes
Waist circumference, waist/hip ratio (cm)
Time frame: 1 year
Body mass index (kg/m2)
Time frame: 1 year
Weight loss
Time frame: 1 year
Change in visceral adipose tissue
Time frame: 1 year
Change in visceral adipose tissue
Time frame: 1 year
Change in ectopic fat
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 33568372Kenkre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tricia Tan, MB ChB principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia S Kenkre, MB BChir (+44208383242, imperial.bariatricstudy@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes remission (partial or complete) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.