Status:
RECRUITING
The Poor Responders Study
Lead Sponsor:
Imperial College London
Conditions:
Bariatric Surgery Candidate
Obesity, Morbid
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 treatme...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05404061
Start Date
August 1 2018
End Date
September 1 2027
Last Update
May 9 2025
Active Locations (1)
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1
Imperial College London
London, United Kingdom, W120NN