ObesityNCT01945840
Gut Hormones and Roux en Y Gastric Bypass
A study testing Roux en Y Gastric Bypass Surgery, Gut hormone infusion and Very low calorie diet in people with Obesity and Type 2 Diabetes, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess whether the changes in gut hormones seen following Roux en Y Gastric Bypass surgery are responsible for some of the beneficial effects seen post-operatively. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Roux en Y Gastric Bypass Surgery, Gut hormone infusion and Very low calorie diet
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to 31 Oct 2028
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 - 70 years.
- Male or female.
- Eligible for bariatric surgery under the NHS.
- Diagnosed with impaired glucose regulation or type 2 diabetes, according to WHO 2011 criteria.
- Those with diabetes should be stable and well controlled with either diet or one oral hypoglycaemic agent.
- HbA1c ≤9.0% or 74.9 mmol/mol.
Who cannot join
- History of any medical, psychological 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 or potentially cause harm to the volunteer.
- Without access at home to a telephone or other factor likely to interfere with ability to participate reliably in the study.
- Pregnancy or breastfeeding.
- Smokers.
- Unable to maintain adequate contraception for the duration of the study and for one month afterwards.
- History of hypersensitivity to any of the components of the subcutaneous infusions.
Show all 17Show fewer
- Donated blood during the preceding 3 months or intention to do so before the end of the study.
- Insulin treatment.
- Uncontrolled hypertension.
- Any other co-morbidity that would compromise the validity of the study or the safety of the participant such as heart failure, clinically apparent cardiovascular disease.
- Volunteers on anti-coagulants such as warfarin and factor Xa inhibitors will not undergo adipose tissue biopsy.
- Unable to give informed consent.
- Previous bariatric surgery.
- Unable to undergo fMRI due to:
- Claustrophobia.
- Pacemaker, metal implant, clips, implanted device, shrapnel or bullet, metal in eyes that precludes magnetic resonance imaging.
- Significant structural abnormality on magnetic resonance brain scan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tricia Tan, MBChB MRCP contact
United Kingdom1 site, 1 recruiting
- Recruiting
NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital
London, Greater London
Stephen R Bloom, PhD
About this study
Official title: Do Gut Hormones Mediate the Beneficial Effects of Roux-en-Y Bypass?
The purpose of this study is to assess whether the changes in gut hormones seen following Roux en Y Gastric Bypass surgery are responsible for some of the beneficial effects seen post-operatively.
Read the detailed description
This study is designed to investigate whether chronic elevation of glucagon-like peptide-1 (GLP-1), oxyntomodulin and peptide YY (PYY) in combination is responsible for the majority of the metabolic effects of Roux-en-Y gastric bypass (RYGB) including improved glycaemia, increased energy expenditure, reduced food intake, weight loss, reduced preference for high calorie foods and reduced activation in brain reward areas in response to visual food cues.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Roux en Y Gastric Bypass Surgery, Gut hormone infusion, Placebo infusion, Very low calorie diet
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux en Y Gastric Bypass SurgeryProcedure or surgery
Gut hormone infusionOther
Placebo infusionOther
Very low calorie dietOther
| Study group | Role | What they receive |
|---|---|---|
| Roux en Y Gastric Bypass | Active comparator | Participants will be those already scheduled to undergo Roux en Y Gastric Bypass Surgery Receives: Procedure: Roux en Y Gastric Bypass Surgery |
| Gut hormone infusion | Experimental | Infusion of three gut hormones (GLP-1, PYY and oxyntomodulin) subcutaneously for 4 weeks as below:
* Combination of GLP-1/OXM/PYY (GOP)
* Single GLP-1
* Single OXM
* Single PYY
* Combination of GLP-1 and OXM
* Combination of GLP-1 and PYY
* Combination of OXM and PYY Receives: Other: Gut hormone infusion |
| Placebo infusion | Placebo comparator | Saline infusion given subcutaneously for 4 weeks. Receives: Other: Placebo infusion |
| Very low calorie diet | Active comparator | Participants will be asked to follow a very low calorie diet for 4 weeks. Receives: Other: Very low calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight loss as measured at baseline compared to 4 weeks after infusion or diet
Measured: Baseline - 4 weeks
Secondary outcomes (1)
Glycaemia
As assessed by change in fructosamine and HbA1c levels
Measured: Baseline - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startOct 2013
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen R Bloom, FRS FRCP MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945840
- Sponsor's protocol ID
- MR/K02115X/1
- Status last verified
- Apr 2021
- First submitted
- 16 Sep 2013
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available
Publications
Alexiadou K, Cuenco J, Howard J, Wewer Albrechtsen NJ, Ilesanmi I, Kamocka A, Tharakan G, Behary P, Bech PR, Ahmed AR, Purkayastha S, Wheller R, Fleuret M, Holst JJ, Bloom SR, Khoo B, Tan TM. Proglucagon peptide secretion profiles in type 2 diabetes before and after bariatric surgery: 1-year prospective study. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e001076. doi: 10.1136/bmjdrc-2019-001076.
PubMed 32209584Ilesanmi I, Tharakan G, Alexiadou K, Behary P, Alessimii H, Bovill-Taylor C, Kenkre J, Choudhury S, Doyle C, Purkayastha S, Miras A, Tsironis C, Chahal H, Bloom SR, Oliver NS, Ahmed AR, Khoo B, Tan TM. Roux-en-Y Gastric Bypass Increases Glycemic Variability and Time in Hypoglycemia in Patients With Obesity and Prediabetes or Type 2 Diabetes: A Prospective Cohort Study. Diabetes Care. 2021 Feb;44(2):614-617. doi: 10.2337/dc20-1609. Epub 2020 Dec 17.
PubMed 33334806Behary P, Tharakan G, Alexiadou K, Johnson N, Wewer Albrechtsen NJ, Kenkre J, Cuenco J, Hope D, Anyiam O, Choudhury S, Alessimii H, Poddar A, Minnion J, Doyle C, Frost G, Le Roux C, Purkayastha S, Moorthy K, Dhillo W, Holst JJ, Ahmed AR, Prevost AT, Bloom SR, Tan TM. Combined GLP-1, Oxyntomodulin, and Peptide YY Improves Body Weight and Glycemia in Obesity and Prediabetes/Type 2 Diabetes: A Randomized, Single-Blinded, Placebo-Controlled Study. Diabetes Care. 2019 Aug;42(8):1446-1453. doi: 10.2337/dc19-0449. Epub 2019 Jun 8.
PubMed 31177183Behary P, Alessimii H, Miras AD, Tharakan G, Alexiadou K, Aldhwayan MM, Purkayastha S, Moorthy K, Ahmed AR, Bloom SR, Tan TM. Tripeptide gut hormone infusion does not alter food preferences or sweet taste function in volunteers with obesity and prediabetes/diabetes but promotes restraint eating: A secondary analysis of a randomized single-blind placebo-controlled study. Diabetes Obes Metab. 2023 Jun;25(6):1731-1739. doi: 10.1111/dom.15028. Epub 2023 Mar 13.
PubMed 36811311Kowalka AM, Alexiadou K, Cuenco J, Clarke RE, Minnion J, Williams EL, Bech P, Purkayastha S, Ahmed AR, Takats Z, Whitwell HJ, Romero MG, Bloom SR, Camuzeaux S, Lewis MR, Khoo B, Tan TM. The postprandial secretion of peptide YY1-36 and 3-36 in obesity is differentially increased after gastric bypass versus sleeve gastrectomy. Clin Endocrinol (Oxf). 2023 Sep;99(3):272-284. doi: 10.1111/cen.14846. Epub 2022 Nov 28.
PubMed 36345253Jones B, Sands C, Alexiadou K, Minnion J, Tharakan G, Behary P, Ahmed AR, Purkayastha S, Lewis MR, Bloom S, Li JV, Tan TM. The Metabolomic Effects of Tripeptide Gut Hormone Infusion Compared to Roux-en-Y Gastric Bypass and Caloric Restriction. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e767-e782. doi: 10.1210/clinem/dgab608.
PubMed 34460933
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Gut Hormones Mediate the Beneficial Effects of Roux-en-Y Bypass?
- ClinicalTrials.gov ID
- NCT01945840
- Acronym / sponsor ID
- MR/K02115X/1
- Conditions
- Obesity, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 19 Sep 2013 (estimated)
- 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.
The purpose of this study is to assess whether the changes in gut hormones seen following Roux en Y Gastric Bypass surgery are responsible for some of the beneficial effects seen post-operatively.
Detailed description
This study is designed to investigate whether chronic elevation of glucagon-like peptide-1 (GLP-1), oxyntomodulin and peptide YY (PYY) in combination is responsible for the majority of the metabolic effects of Roux-en-Y gastric bypass (RYGB) including improved glycaemia, increased energy expenditure, reduced food intake, weight loss, reduced preference for high calorie foods and reduced activation in brain reward areas in response to visual food cues.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Roux en Y Gastric Bypass | Active comparator | Procedure: Roux en Y Gastric Bypass SurgeryParticipants will be those already scheduled to undergo Roux en Y Gastric Bypass Surgery |
| Gut hormone infusion | Experimental | Other: Gut hormone infusionInfusion of three gut hormones (GLP-1, PYY and oxyntomodulin) subcutaneously for 4 weeks as below: * Combination of GLP-1/OXM/PYY (GOP) * Single GLP-1 * Single OXM * Single PYY * Combination of GLP-1 and OXM * Combination of GLP-1 and PYY * Combination of OXM and PYY |
| Placebo infusion | Placebo comparator | Other: Placebo infusionSaline infusion given subcutaneously for 4 weeks. |
| Very low calorie diet | Active comparator | Other: Very low calorie dietParticipants will be asked to follow a very low calorie diet for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 - 70 years.
- Male or female.
- Eligible for bariatric surgery under the NHS.
- Diagnosed with impaired glucose regulation or type 2 diabetes, according to WHO 2011 criteria.
- Those with diabetes should be stable and well controlled with either diet or one oral hypoglycaemic agent.
Key exclusion criteria (17 listed)
- History of any medical, psychological 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 or potentially cause harm to the volunteer.
- Without access at home to a telephone or other factor likely to interfere with ability to participate reliably in the study.
- Pregnancy or breastfeeding.
- Smokers.
- Unable to maintain adequate contraception for the duration of the study and for one month afterwards.
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 Surgery | Procedure or surgery | Roux en Y Gastric Bypass |
| Gut hormone infusion | Other | Gut hormone infusion |
| Placebo infusion | Other | Placebo infusion |
| Very low calorie diet | Other | Very low calorie diet |
Primary outcome
Weight loss
Time frame: Baseline - 4 weeks
Weight loss as measured at baseline compared to 4 weeks after infusion or diet
1 secondary outcome
Glycaemia
Time frame: Baseline - 4 weeks
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 20 Apr 2021.
- Background: PubMed 32209584Alexiadou K, Cuenco J, Howard J, Wewer Albrechtsen NJ, Ilesanmi I, Kamocka A, Tharakan G, Behary P, Bech PR, Ahmed AR, Purkayastha S, Wheller R, Fleuret M, Holst JJ, Bloom SR, Khoo B, Tan TM. Proglucagon peptide secretion profiles in type 2 diabetes before and after bariatric surgery: 1-year prospective study. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e001076. doi: 10.1136/bmjdrc-2019-001076.
- Background: PubMed 33334806Ilesanmi I, Tharakan G, Alexiadou K, Behary P, Alessimii H, Bovill-Taylor C, Kenkre J, Choudhury S, Doyle C, Purkayastha S, Miras A, Tsironis C, Chahal H, Bloom SR, Oliver NS, Ahmed AR, Khoo B, Tan TM. Roux-en-Y Gastric Bypass Increases Glycemic Variability and Time in Hypoglycemia in Patients With Obesity and Prediabetes or Type 2 Diabetes: A Prospective Cohort Study. Diabetes Care. 2021 Feb;44(2):614-617. doi: 10.2337/dc20-1609. Epub 2020 Dec 17.
- Results publication: PubMed 31177183Behary P, Tharakan G, Alexiadou K, Johnson N, Wewer Albrechtsen NJ, Kenkre J, Cuenco J, Hope D, Anyiam O, Choudhury S, Alessimii H, Poddar A, Minnion J, Doyle C, Frost G, Le Roux C, Purkayastha S, Moorthy K, Dhillo W, Holst JJ, Ahmed AR, Prevost AT, Bloom SR, Tan TM. Combined GLP-1, Oxyntomodulin, and Peptide YY Improves Body Weight and Glycemia in Obesity and Prediabetes/Type 2 Diabetes: A Randomized, Single-Blinded, Placebo-Controlled Study. Diabetes Care. 2019 Aug;42(8):1446-1453. doi: 10.2337/dc19-0449. Epub 2019 Jun 8.
- Derived from this study: PubMed 36811311Behary P, Alessimii H, Miras AD, Tharakan G, Alexiadou K, Aldhwayan MM, Purkayastha S, Moorthy K, Ahmed AR, Bloom SR, Tan TM. Tripeptide gut hormone infusion does not alter food preferences or sweet taste function in volunteers with obesity and prediabetes/diabetes but promotes restraint eating: A secondary analysis of a randomized single-blind placebo-controlled study. Diabetes Obes Metab. 2023 Jun;25(6):1731-1739. doi: 10.1111/dom.15028. Epub 2023 Mar 13.
- Derived from this study: PubMed 36345253Kowalka AM, Alexiadou K, Cuenco J, Clarke RE, Minnion J, Williams EL, Bech P, Purkayastha S, Ahmed AR, Takats Z, Whitwell HJ, Romero MG, Bloom SR, Camuzeaux S, Lewis MR, Khoo B, Tan TM. The postprandial secretion of peptide YY1-36 and 3-36 in obesity is differentially increased after gastric bypass versus sleeve gastrectomy. Clin Endocrinol (Oxf). 2023 Sep;99(3):272-284. doi: 10.1111/cen.14846. Epub 2022 Nov 28.
- Derived from this study: PubMed 34460933Jones B, Sands C, Alexiadou K, Minnion J, Tharakan G, Behary P, Ahmed AR, Purkayastha S, Lewis MR, Bloom S, Li JV, Tan TM. The Metabolomic Effects of Tripeptide Gut Hormone Infusion Compared to Roux-en-Y Gastric Bypass and Caloric Restriction. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e767-e782. doi: 10.1210/clinem/dgab608.
- Individual participant dataSharing planned: No. No plan to make IPD available
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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, MBChB MRCP contact
Stephen R Bloom, FRS FRCP MD 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?
A study testing Roux en Y Gastric Bypass Surgery, Gut hormone infusion and Very low calorie diet in people with Obesity and Type 2 Diabetes, 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 6 inclusion and 17 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 20 Apr 2021. 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. Some participants in this study may receive a placebo. 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 Tricia Tan, MBChB MRCP (t.tan@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: Baseline - 4 weeks). 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 NCT01945840, which also lists 6 linked publications.
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 20 Apr 2021.