Investigation of the Metabolic Effects of 3mg Liraglutide on Patients With Overweight or Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Weight changes related to treatment
Study Overview
Brief Summary
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.
Detailed Description
- Obesity is a global pandemic with debilitating consequences. It affects both adults and children; however, the prevalence of overweight and obesity among children and adolescents aged 5-19 has risen dramatically from just 4% in 1975 to just over 18% in 2016, highlighting the seriousness of this problem. The rise has occurred similarly among both boys and girls: in 2016 18% of girls and 19% of boys were overweight. While just under 1% of children and adolescents aged 5-19 were obese in 1975, more 124 million children and adolescents (6% of girls and 8% of boys) were obese in 2016.
Obesity is a major risk factor for noncommunicable diseases such as:
- Cardiovascular diseases (mainly heart disease and stroke), which were the leading cause of death in United States of America(USA);
- Diabetes Mellitus
- Musculoskeletal disorders (especially osteoarthritis - a highly disabling degenerative disease of the joints);
- Some forms of malignancy (including endometrial, breast, ovarian, prostate, liver, gallbladder, kidney, and colon);
- Infertility in both women and men. The risk for these noncommunicable diseases increases, with increases in Body Mass Index (BMI).
- Liraglutide is a derivative of human incretin (metabolic hormone) glucagon-like peptide-1 (GLP-1) that is used as a long-acting glucagon-like peptide-1 receptor agonist, binding to the same receptors as does the endogenous metabolic hormone GLP-1 that stimulates insulin secretion. Liraglutide is licenced in USA and in European Union (EU), including United Kingdom (UK) for the management of Type 2 Diabetes Mellitus (T2DM) and Obesity or overweight when one or more metabolic co-morbidities are present.
Saxenda (3mg Liraglutide once daily) is an Food & Drug Administration (FDA)-approved, prescription injectable Glucagon Like Peptide-1 (GLP-1) receptor agonist that, when used with a low-calorie diet and increased physical activity, can reduce excess weight in patients who are overweight (BMI ≥27Kg/m2) and additionally have weight-related medical problems (such as high blood pressure, high cholesterol, or insulin resistance/pre-diabetes), or obesity (BMI: >30Kg/m2) to lose weight. Saxenda is licensed and available in the UK for the management of obesity and overweight.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
Overweight/obese participants
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.
Intervention: Saxenda (Drug)
Overweight/obese participants
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.
Intervention: Lifestyle modification (Other)
Overweight/obese participants
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.
Intervention: Metabolomics (Diagnostic Test)
Overweight/obese participants
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.
Intervention: miRNA (Diagnostic Test)
Outcomes
Primary Outcomes
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:
Secondary Outcomes
- Changes in the expression of miRNA-155 while on treatment.(6 months)
- Changes in the expression of miRNA-221 while on treatment.(6 months)
- Changes in the expression of miRNA-222 while on treatment.(6 months)
- Changes in glucose and insulin from baseline.(6 months)
- Changes in fat and lean mass while on treatment(6 months)
- Changes in an untargeted study of water-soluble metabolites (HILIC LCMS) while on treatment(6 months)
- Changes in an untargeted study of lipid metabolites (C18 reversed phase LCMS) while on treatment(6 months)
- Changes in systolic blood pressure.(6 months)
- Changes in heart rate.(6 months)
- Changes diastolic blood pressure.(6 months)