Clinical trial

Investigation of the Metabolic Effects of 3mg Liraglutide on Patients With Overweight or Obesity

Name
GD410218
Description
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.
Trial arms
Trial start
2019-01-18
Estimated PCD
2020-12-18
Trial end
2020-12-18
Status
Completed
Treatment
Saxenda
Obesity pharmacotherapy
Arms:
Overweight/obese participants
Lifestyle modification
Tier 3 NHS weight management
Arms:
Overweight/obese participants
Metabolomics
Small molecule intermediates and products of metabolism
Arms:
Overweight/obese participants
miRNA
Small non-coding RNA molecules
Arms:
Overweight/obese participants
Size
43
Primary endpoint
Weight changes related to treatment
6 months
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 43, 'type': 'ACTUAL'}}
Updated at
2024-06-18

1 organization

1 product

3 indications

Product
Saxenda
Indication
Obesity
Indication
infertility
Indication
Woman