Obesity Clinical Trial
— BARIOPTIMISEOfficial title:
BARI-OPTIMISE: a Double-blinded, Randomised, Placebo-controlled Trial of Liraglutide 3.0 mg in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response Following Bariatric Surgery
Verified date | November 2020 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A double-blinded, randomised, placebo-controlled trial of liraglutide 3.0 mg in patients with poor weight-loss and a suboptimal glucagon-like peptide-1 response following bariatric surgery
Status | Completed |
Enrollment | 70 |
Est. completion date | June 11, 2020 |
Est. primary completion date | November 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: 1. Patients, 1 year or more after primary RYGB or primary SG, with poor weight-loss (<20% WL) that is not caused by either a surgical or psychological problem. 2. Adults, 18-64 years inclusive. 3. Suboptimal nutrient-stimulated GLP-1 response assessed by a meal test. Suboptimal active GLP-1 response is defined as a =2-fold increase in active GLP-1 circulating levels between time 0 and time 30 minutes. 4. Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control, abstinence) from the time consent is signed until 6 weeks after treatment discontinuation. 5. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment. NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. 6. =5 % variation in body weight over preceding 3 months. 7. Fluent in English and able to understand and complete questionnaires. 8. Willing and able to provide written informed consent and comply with the trial protocol. Exclusion Criteria: 1. Had a surgical procedure other than gastric bypass and sleeve gastrectomy. 2. Pregnant or lactating mothers. 3. Participation in other clinical intervention trial. 4. Lifetime history of suicidal behaviour or severe depression assessed by direct questioning. 5. Clinically significant medical abnormalities (e.g., unstable hypertension, clinically significant ECG abnormalities, liver cirrhosis, AST or ALT > 3x the upper normal limit). 6. Heart rate = 100 beats/minute at screening on two separate measurements. 7. Uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg). 8. Renal impairment (estimated glomerular infiltration rate (eGFR <30 ml/min 1.73 m2) 9. Known or suspected hypersensitivity to liraglutide 3.0 mg and placebo or any of the excipients involved in their formulation. 10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. 11. Personal history of pancreatitis. 12. Uncontrolled hypothyroidism or hyperthyroidism. 13. History of stroke, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months. 14. History of arrhythmias. 15. Inflammatory bowel disease. 16. Diabetic gastroparesis. 17. Concomitant GLP-1 receptor agonist usage. 18. Concomitant usage of medications that cause weight gain or weight loss. 19. Concomitant usage of DPPIV-inhibitors. 20. Insulin usage. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | UCLH | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | %WL | The primary objective of this trial is to compare the efficacy of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration, as an adjunct to diet and exercise, on %WL in participants with poor weight-loss and a sub-optimal active GLP-1 response following primary RYGB or SG at the end of the 24-week treatment period. | 24 weeks | |
Secondary | %fat | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on % body fat assessed using DXA scanning | 24 weeks | |
Secondary | Skeletal muscle mass | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on skeletal muscle mass assessed using DXA scanning | 24 weeks | |
Secondary | Bone mineral density | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on bone mineral density assessed using DXA scanning | 24 weeks | |
Secondary | Glucose level | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of glucose assessed using blood test | 24 weeks | |
Secondary | Insulin | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of insulin assessed using blood test | 24 weeks | |
Secondary | HbA1c | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of HbA1c assessed using blood test | 24 weeks | |
Secondary | Leptin | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of leptin assessed using blood test | 24 weeks | |
Secondary | Gut Hormones | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of gut hormones assessed using blood test | 24 weeks | |
Secondary | Adipokines | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of adipokines assessed using blood test | 24 weeks | |
Secondary | physical functional assessment | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on physical functioning assessed using the 6-minute walk test (6-MWT) | 24 weeks | |
Secondary | physical function assessment | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on physical functioning assessed using the sit-to-stand test (STS Test) | 24 weeks | |
Secondary | physical function assessment | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on physical functioning assessed using hand-grip strength | 24 weeks | |
Secondary | physical function assessment | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on physical functioning assessed using the Paffenbarger Physical Activity Questionnaire (PPAQ) | 24 weeks | |
Secondary | HRQoL | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on health related quality of life assessed using an adapted Client Service Receipt Inventory (CSRI) | 24 weeks | |
Secondary | HRQoL | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on health related quality of life assessed using EuroQol-5D (ED5DEQ-5D) | 24 weeks | |
Secondary | HRQoL | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on health related quality of life assessed using Impact of weight on quality of life-lite (IWQOL-Lite) | 24 weeks | |
Secondary | HRQoL | To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on health related quality of life assessed using Beck depression inventory (BDI) | 24 weeks |
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