Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05404061

The Poor Responders Study

Led by Imperial College London · Updated on 2025-05-09

220

Participants Needed

1

Research Sites

474 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Poor Responders Study

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 -70 years.
  • Male or female.
  • Previous bariatric surgery for obesity and/or diabetes (studies 1 and 2).
  • At least 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.
Not Eligible

You will not qualify if you...

  • Any medical, psychological, or other condition, or use of medications, that may interfere with the study or cause harm.
  • No access at home to a telephone or other factor likely to interfere with reliable participation.
  • Pregnancy or breastfeeding.
  • Unable to maintain adequate contraception during the study and for one month after.
  • History of hypersensitivity to components of the subcutaneous infusions.
  • Donated blood during the preceding 3 months or intention to do so before study end.
  • Any co-morbidity compromising study validity or participant safety, such as heart failure or cardiovascular disease.
  • Anatomical or endocrinological problems causing poor weight loss or weight regain.
  • Uncontrolled hypertension (systolic ≥160 mmHg and/or diastolic ≥100 mmHg).
  • Participation in another research study within the last two months.
  • Unable to speak English (relevant for psychological questionnaires).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Imperial College London

London, United Kingdom, W120NN

Actively Recruiting

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Research Team

K

Kleopatra Alexiadou, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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