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3mg Liraglutide for Overweight or Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885297
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
Kingston University
University of Warwick
University of Birmingham
Information provided by (Responsible Party):
University Hospitals Coventry and Warwickshire NHS Trust

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.


Condition or disease Intervention/treatment
Overweight Obesity Infertility, Female Drug: Saxenda Other: Lifestyle modification Diagnostic Test: Metabolomics Diagnostic Test: miRNA

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Liraglutide

Group/Cohort Intervention/treatment
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.
Drug: Saxenda
Obesity pharmacotherapy

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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).

  3. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. Changes in systolic blood pressure. [ Time Frame: 6 months ]
    We will measure systolic blood pressure changes from baseline while on treatment.

  9. Changes diastolic blood pressure. [ Time Frame: 6 months ]
    We will measure diastolic blood pressure changes from baseline while on treatment.

  10. Changes in heart rate. [ Time Frame: 6 months ]
    We will measure heart rate changes from baseline.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Investigators don't anticipate any specific difficulties with recruitment for this study as overweight and obesity are very common conditions, and there are very few licensed medical options offering substantial weight loss. Liraglutide is one of them. Additionally, investigators don't see any specific difficulties in managing this study as it will be " part and parcel" of our patients' routine clinical visits. Liraglutide is going to be offered to our patients as per clinical need and the decision to treat them with liraglutide is going to be made before their potential participation in our study. Patients therefore are not going to be receiving treatment because of their participation in our study.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Georgios K. Dimitriadis, MD, MSc, PhDc 02476965249 ext 25249 georgios.dimitriadis@uhcw.nhs.uk
Contact: Diane Sambrook 02476965249 ext 02476965249 diane.sambrook@uhcw.nhs.uk

Locations
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United Kingdom
WISDEM Centre, University Hospitals Coventry and Warwickshire Recruiting
Coventry, West Midlands, United Kingdom, CV2 2DX
Contact: Diane Sambrook    00442476965249 ext 25249    diane.sambrook@uhcw.nhs.uk   
Contact: Danielle Bate    00442476966019 ext 26019    danielle.bate@uhcw.nhs.uk   
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Kingston University
University of Warwick
University of Birmingham
Investigators
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Principal Investigator: Georgios K. Dimitriadis University Hospitals Coventry and Warwickshire NHS Trust
Publications:
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Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT03885297    
Other Study ID Numbers: GD410218
250896 ( Registry Identifier: IRAS ID number )
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
obesity
metabolism
liraglutide
saxenda
metabolomics
miRNA
weight loss
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Genital Diseases, Male
Genital Diseases, Female
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists