Obesity Clinical Trial
Official title:
Investigation of the Metabolic Effects of 3mg Liraglutide on Patients With Overweight or Obesity
In this study investigators will investigate the beneficial metabolic sequelae of Liraglutide
in patients with obesity or overweight; including changes in vital signs, anthropometric
characteristics (weight, body mass index and body composition), biochemical parameters,
metabolomics and micro-ribonucleotide acid (miRNA) molecules from blood tests. Liraglutide is
a commercially available analogue of a gut hormone physiologically produced in our bowel in
response to food, licenced for the treatment of overweight or obesity. Liraglutide will be
offered to patients attending National Health System (NHS) or private clinics within
indication and according to their agreed clinical management. Investigators aim to collect
real-life information for this study along with planned clinical management from patients who
agree to their treatment and to take part in our study. Patients will be able to withdraw
from treatment and study at any time without giving any explanation.
If successful, this study will help us combine clinical, biochemical and molecular
information which will allow us to gain deeper understanding on the mechanisms behind the
beneficial metabolic effects of Liraglutide in overweight and obesity. Data generated from
this study will hopefully help us acquire funding for a larger multicentre study; the results
of which can have substantial impact on millions of people with overweight or obesity around
the world.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 18, 2021 |
Est. primary completion date | July 18, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult participants [age =18 y.o without upper age limit (to the discretion of the investigators)]. - Body mass index (BMI) = 30 kg/m2 without coexisting comorbidities or BMI =27Kg/m2 with comorbidities like hypertension, hyperlipidaemia, prediabetes or obstructive sleep apnoea. - Willing to comply with study requirements and able to give informed consent. Exclusion Criteria: - Type 1 or Type 2 diabetes mellitus - History of chronic or acute pancreatitis - Known active hepatitis or active liver disease - Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease - Persistent anaemia, defined as haemoglobin<10 g/dl - Chronic or acute renal impairment (eGFR <30 ml/min/1.73m2) - Active systemic infection (sepsis) - Active malignancy within the last 5 years, including any form of thyroid cancer (including sporadic or familial medullary thyroid cancer) or personal, or family history of Multiple Endocrine Neoplasia type 2. - Active illicit substance abuse or alcoholism - Current pregnancy or breastfeeding at screening or 6 months previously - Donated blood during the preceding 3 months or intention to do so before the end of the study. - Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | WISDEM Centre, University Hospitals Coventry and Warwickshire | Coventry | West Midlands |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Coventry and Warwickshire NHS Trust | Kingston University, University of Birmingham, University of Warwick |
United Kingdom,
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FDA approves weight-management drug Saxenda
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm198638.htm
James WP. WHO recognition of the global obesity epidemic. Int J Obes (Lond). 2008 Dec;32 Suppl 7:S120-6. doi: 10.1038/ijo.2008.247. Review. — View Citation
Jordan KW, Nordenstam J, Lauwers GY, Rothenberger DA, Alavi K, Garwood M, Cheng LL. Metabolomic characterization of human rectal adenocarcinoma with intact tissue magnetic resonance spectroscopy. Dis Colon Rectum. 2009 Mar;52(3):520-5. doi: 10.1007/DCR.0b013e31819c9a2c. — View Citation
WHO annual report 2017; Obesity update - © OECD 2017
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight changes related to treatment | Weight reduction in kilograms from baseline while on treatment with 3mg Liraglutide once daily in patients with overweight (BMI: =27Kg/m2) or obesity (BMI: =30Kg/m2) with regards to: | 6 months | |
Secondary | Changes in fat and lean mass while on treatment | Fat and lean mass changes in percentages from baseline using air displacement plethysmography and bioelectrical impedance techniques while on treatment with 3mg Liraglutide once daily for overweight and obesity | 6 months | |
Secondary | Changes in an untargeted study of water-soluble metabolites (HILIC LCMS) while on treatment | Ultra Performance Liquid Chromatography-Mass Spectrometry (UPLC-MS) will be performed to measure plasma changes of water-soluble metabolites (HILIC LCMS). | 6 months | |
Secondary | Changes in an untargeted study of lipid metabolites (C18 reversed phase LCMS) while on treatment | Ultra Performance Liquid Chromatography-Mass Spectrometry (UPLC-MS) will be performed to measure plasma changes of lipid metabolites (C18 reversed phase LCMS) | 6 months | |
Secondary | Changes in the expression of miRNA-155 while on treatment. | Decreased expression of miRNA-155 has been found during the adipogenic programming of both immortalized and primary hMSCs, suggesting that it acts as negative regulators of fat cell differentiation. We will measure this in plasma. | 6 months | |
Secondary | Changes in the expression of miRNA-221 while on treatment. | Decreased expression of miRNA-221 has been found during the adipogenic programming of both immortalized and primary hMSCs, suggesting that it acts as negative regulators of fat cell differentiation. We will measure this in plasma. | 6 months | |
Secondary | Changes in the expression of miRNA-222 while on treatment. | Decreased expression of miRNA-222, has been found during the adipogenic programming of both immortalized and primary hMSCs, suggesting that it acts as negative regulators of fat cell differentiation. We will measure this in plasma. | 6 months | |
Secondary | Changes in glucose and insulin from baseline. | We will measure changes in serum glucose and insulin from baseline while on treatment using ELISA (enzyme-linked immunosorbent assay). | 6 months | |
Secondary | Changes in systolic blood pressure. | We will measure systolic blood pressure changes from baseline while on treatment. | 6 months | |
Secondary | Changes diastolic blood pressure. | We will measure diastolic blood pressure changes from baseline while on treatment. | 6 months | |
Secondary | Changes in heart rate. | We will measure heart rate changes from baseline. | 6 months |
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