Why do Some Patients Respond Better Than Others to Bariatric Surgery?

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Imperial College London
RECRUITING
London
Contact Information
Primary
Kleopatra Alexiadou, PhD
k.alexiadou@imperial.ac.uk
+442033138038
Time Frame
Start Date: 2018-08-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 220
Treatments
No_intervention: Gut hormone secretion study
This will be a retrospective study of participants who have undergone bariatric surgery. On the day of the visit participants will undergo comprehensive physiological profiling which will include the following tests:~* Body weight and bioelectrical impedance analysis~* Mixed Meal Tolerance Test. This will be analysed for metabolites including gut hormones, insulin, glucose, bile acids and their sub-fractions, fibroblast-growth factors, lipids and immune profiles.~* Resting Energy Expenditure and Diet Induced Thermogenesis assessed via Indirect Calorimetry~* Metabolomic and Metagenomic Assessment
Placebo_comparator: Gut hormone sensitivity study
This will be a single blinded study with participants attending three visits. 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). This will not only allow us to acclimatise the study volunteer to the study visits, but also allow us to test for subject tolerability of the gut hormones. Occasionally some volunteers are more sensitive to the gut hormone infusion and the doses needs to be titrated down. The doses used will be established doses of the gut hormones infused previously and which have been shown to be safe and tolerated, and to reduce appetite (In house data).
No_intervention: Prospective assessment of gut hormone response pre and post-surgery
This will be a prospective study assessing the gut hormone response pre and post bariatric surgery.~On the day of the visit participants will undergo comprehensive physiological profiling which will include the following tests:~* Body weight and bioelectrical impedance analysis~* Mixed Meal Tolerance Test. This will be analysed for metabolites including gut hormones, insulin, glucose, bile acids and their sub-fractions, fibroblast-growth factors, lipids and immune profiles.~* Resting Energy Expenditure and Diet Induced Thermogenesis assessed via Indirect Calorimetry~* Metabolomic and Metagenomic Assessment
Related Therapeutic Areas
Sponsors
Leads: Imperial College London

This content was sourced from clinicaltrials.gov