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The Poor Responders Study

Sponsor: Imperial College London

NCT ID: NCT05404061

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Gut hormones (other)
How long the study runs
Study runs about 109 months (dates as stated)
About the drug or intervention
Gut hormones — other: Their first visit will act as an acclimatisation visit and participants will be infused subcutaneously with a triple gut hormone infusion (GLP-1, PYY and OXM).
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 70 Years
Who
All
Number of participants
220
Started
2018-08-01
Last checked
2025-05

Plain English Summary

What is this study?

  • • Testing a new treatment for bariatric surgery candidate
  • • NA - 220 participants
  • • Obesity and type 2 diabetes are major causes of illness and premature death worldwide and their incidence is increasing rapidly

Who can take part?

  • • Ages 18 Years to 70 Years
  • • Diagnosed with bariatric surgery candidate

Where?

  • • London - Imperial College London

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Obesity and type 2 diabetes are major causes of illness and premature death worldwide and their incidence is increasing rapidly. Bariatric surgery is considered as the "gold-standard" surgical treatment for both conditions. However, not all patients do equally well after surgery and indeed the weight loss experienced by patients undergoing bariatric surgery can vary. As such when patients are seen after bariatric surgery in clinic they fall in one of the following two categories: 1. Good responders: this is the majority of patients who lose the expected amount of weight based on the published studies. 2. Poor responders: this is a small group of patients who either lose less than the expected amount of weight after bariatric surgery or lose the expected amounts of weight early after surgery but then regain a substantial proportion of the weight they have lost. The so-called "poor responders" are exposed to all the risks of the operation and do not benefit from the weight loss as much as good responders. This study would therefore like to investigate the physiological factors that distinguish poor from good responders before, and after bariatric surgery. The study team hypothesizes that compared to good responders, poor responders exhibit: 1. a smaller degree of fullness sensation after a meal, 2. a lower energy expenditure after a meal, and 3. genetic changes (single nucleotide polymorphisms) that predispose the poor responder to development of obesity. In addition, the study team hypothesizes that poor responders exhibit: 1. lower gut hormone secretion after a meal and 2. are less sensitive to the physiological action of gut hormones compared to good responders and that this difference in gut hormone secretion and response to gut hormones prior to bariatric surgery can be helpful to predict response to bariatric surgery.

Bariatric Surgery CandidateObesity, MorbidDiabetes Mellitus, Type 2

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 70 Years
  • Who can join: All genders

What the study is looking for

  • ✓Aged 18 -70 years.
  • ✓Male or female.
  • ✓Previous bariatric surgery for obesity and/or diabetes (studies 1 and 2).
  • ✓≥1 year interval after bariatric surgery (studies 1 and 2).
  • ✓Awaiting bariatric surgery at the Imperial Weight Centre (study 3)

Who cannot take part

  • ✗Without access at home to a telephone or other factor likely to interfere with ability to participate reliably in...
  • ✗Pregnancy or breastfeeding.
  • ✗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.
See the full criteria
Inclusion Criteria: * Aged 18 -70 years. * Male or female. * Previous bariatric surgery for obesity and/or diabetes (studies 1 and 2). * ≥1 year interval after bariatric surgery (studies 1 and 2). * Awaiting bariatric surgery at the Imperial Weight Centre (study 3) * Able to give informed consent. 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. * 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. * Any other co-morbidity that would compromise the validity of the study or the safety of the participant such as heart failure or clinically apparent cardiovascular disease. * Anatomical or endocrinological pathology causing poor weight loss or weight regain * Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above) * Participation in a research study within the last two months. * Unable to speak English (this is relevant to answering the psychological questionnaires)

Where Is This Study? (1 UK site)

Imperial College London

London W120NN, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Kleopatra Alexiadou, PhD

Sponsor contact

CONTACT

+442033138038 k.alexiadou@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-05