3mg Liraglutide for Overweight or Obesity
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|ClinicalTrials.gov Identifier: NCT03885297|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
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.
|Condition or disease||Intervention/treatment|
|Overweight Obesity Infertility, Female||Drug: Saxenda Other: Lifestyle modification Diagnostic Test: Metabolomics Diagnostic Test: miRNA|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Investigation of the Metabolic Effects of 3mg Liraglutide on Patients With Overweight or Obesity|
|Actual Study Start Date :||January 18, 2019|
|Estimated Primary Completion Date :||July 18, 2020|
|Estimated Study Completion Date :||January 18, 2021|
Patients will be recruited prospectively from the weight management and Polycystic Ovary Syndrome (PCOS) clinics at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust following discussion with their treating physician, who will also be a member of the research team and joint agreement on initiation of treatment with 3mg Liraglutide once daily as per clinical management plan. Patients will additionally receive standard NHS Tier 3 lifestyle advice and support for the duration of the study. Lifestyle modification aimed at weight loss will be delivered by a dietician or other trained health care professional within individual sessions for a period of 6 months. Finally, all patients will be able to withdraw from treatment and/or the study at any point without giving any explanation. This will have no impact in their clinical management.
Other: Lifestyle modification
Tier 3 NHS weight management
Diagnostic Test: Metabolomics
Small molecule intermediates and products of metabolism
Diagnostic Test: miRNA
Small non-coding RNA molecules
- Weight changes related to treatment [ Time Frame: 6 months ]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:
- Changes in fat and lean mass while on treatment [ Time Frame: 6 months ]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
- Changes in an untargeted study of water-soluble metabolites (HILIC LCMS) while on treatment [ Time Frame: 6 months ]Ultra Performance Liquid Chromatography-Mass Spectrometry (UPLC-MS) will be performed to measure plasma changes of water-soluble metabolites (HILIC LCMS).
- Changes in an untargeted study of lipid metabolites (C18 reversed phase LCMS) while on treatment [ Time Frame: 6 months ]Ultra Performance Liquid Chromatography-Mass Spectrometry (UPLC-MS) will be performed to measure plasma changes of lipid metabolites (C18 reversed phase LCMS)
- Changes in the expression of miRNA-155 while on treatment. [ Time Frame: 6 months ]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.
- Changes in the expression of miRNA-221 while on treatment. [ Time Frame: 6 months ]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.
- Changes in the expression of miRNA-222 while on treatment. [ Time Frame: 6 months ]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.
- Changes in glucose and insulin from baseline. [ Time Frame: 6 months ]We will measure changes in serum glucose and insulin from baseline while on treatment using ELISA (enzyme-linked immunosorbent assay).
- Changes in systolic blood pressure. [ Time Frame: 6 months ]We will measure systolic blood pressure changes from baseline while on treatment.
- Changes diastolic blood pressure. [ Time Frame: 6 months ]We will measure diastolic blood pressure changes from baseline while on treatment.
- Changes in heart rate. [ Time Frame: 6 months ]We will measure heart rate changes from baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885297
|Contact: Georgios K. Dimitriadis, MD, MSc, PhDc||02476965249 ext email@example.com|
|Contact: Diane Sambrook||02476965249 ext firstname.lastname@example.org|
|WISDEM Centre, University Hospitals Coventry and Warwickshire||Recruiting|
|Coventry, West Midlands, United Kingdom, CV2 2DX|
|Contact: Diane Sambrook 00442476965249 ext 25249 email@example.com|
|Contact: Danielle Bate 00442476966019 ext 26019 firstname.lastname@example.org|
|Principal Investigator:||Georgios K. Dimitriadis||University Hospitals Coventry and Warwickshire NHS Trust|