GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01945840

RecruitingPhase NA

Gut Hormones and Roux en Y Gastric Bypass

Do Gut Hormones Mediate the Beneficial Effects of Roux-en-Y Bypass?

Lead sponsor

Imperial College London

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Enrollment

190

estimated

Study population

Bariatric Surgery, Obesity / overweight, Prediabetes / glucose intolerance, Type 2 diabetes

Key I/E criterion

•HbA1c ≤9%

Primary endpoint

•Weight loss

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01945840

Org study IDMR/K02115X/1

Timeline

Milestones

Study first posted2013-09-19estimated

Last update posted2021-04-20actual

Primary completion2028-10-31estimated

Study completion2028-10-31estimated

Study start2013-10 (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweightPrediabetes / glucose intoleranceType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•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.

Exclusion criteria

•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.

•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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Weight & body composition

1 endpoint

Primary/protocol endpoint

Weight loss

Time frame:Baseline - 4 weeks

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Glycaemia

Time frame:Baseline - 4 weeks

change from baseline, improvement

componentsHbA1c, change

Publications (6)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

The postprandial secretion of peptide YY(1-36) and (3-36) in obesity is differentially increased after gastric bypass versus sleeve gastrectomy.
Clinical endocrinology2023 Sep (month)PMID36345253doi:10.1111/cen.14846via clinicaltrials gov reference derived + pubmed nct search
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, obesity & metabolism2023 Jun (month)PMID36811311doi:10.1111/dom.15028via clinicaltrials gov reference derived + pubmed nct search
The Metabolomic Effects of Tripeptide Gut Hormone Infusion Compared to Roux-en-Y Gastric Bypass and Caloric Restriction.
The Journal of clinical endocrinology and metabolism2022 Jan 18PMID34460933doi:10.1210/clinem/dgab608via clinicaltrials gov reference derived + pubmed nct search
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 care2021 Feb (month)PMID33334806doi:10.2337/dc20-1609via CT.gov background
Proglucagon peptide secretion profiles in type 2 diabetes before and after bariatric surgery: 1-year prospective study.
BMJ open diabetes research & care2020 Mar (month)PMID32209584doi:10.1136/bmjdrc-2019-001076via CT.gov background + pubmed nct search
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 care2019 Aug (month)PMID31177183doi:10.2337/dc19-0449via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.