Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-70 years 2. BMI 35-50 kg/m² 3. Ability to lie supine 4. Appropriate anatomy of the left gastric artery and coeliac plexus on CT angiogram 5. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Haematological, hepatic or renal dysfunction 2. Weight >150 kg 3. HbA1c >8.5% 4. Known renal, vascular or aortic disease 5. Malignancy 6. Prior major abdominal surgery, prior gastric or bariatric surgery 7. Prior abdominal radiotherapy 8. Gastrointestinal (GI) bleeding or bleeding diathesis 9. Allergy to iodinated contrast, 10. Known gastric ulceration or active H. pylori infection 11. Positive pregnancy test in females of childbearing age 12. Chronic Non-steroidal anti-inflammatory drug (NSAID) use 13. Current use of insulin or sulphonylurea 14. Current use of anti-tricyclic anti-depressants or steroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute difference in percent weight loss (in kg) measured using weighing scales between baseline weight and weight at 12 months post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute difference in percent weight loss (in kg) measured using weighing scales between baseline weight and weight at 3 and 6 months 2. Total body loss (TBL) i.e. the absolute change in weight (in kg) measured using weighing scales from baseline to 12 months 3. Proportion of patients in each arm with =5% TBL measured using weighing scales at 12 months 4. Gut hormones (e.g. blood test for ghrelin, PYY, GLP-1) measured at baseline, month 3, month 6 and month 12 5. Hunger and satiety scores obtained using Visual Analogue Scales at baseline, month 3, month 6 and month 12 6. Food intake measured using meal test and food diaries at baseline, month 3, month 6 and month 12 7. Delay in gastric emptying measured using paracetamol test using participants plasma sample measured at baseline, month 3, month 6 and month 12 8. Eating behaviour and quality of life measured using questionnaires (SF36-V2, IQWOL lite, HADS, DEBQ, EPIC FFQ) at baseline, month 3, month 6 and month 12 9. Markers of obesity-related complications measured by blood tests for HbA1c, fasting glucose, insulin and blood pressure recording at baseline, month 3, month 6 and month 12 10. Frequency of adverse events based on the clinical judgement of the investigator at month 3, month 6 and month 12 11. Preference of treatment arm recorded by asking the participant to indicate their treatment arm preference meaning that they will need to answer the following question during visits at months 3, 6 and 12: ‘Knowing what has happened now - would you have chosen the same procedure? | — |
Countries
England, United Kingdom