Status:
UNKNOWN
Combined Effects of GLP-1 Analogue and Exercise on Maintenance of Weight Loss and Health After Very-low Calorie Diet
Lead Sponsor:
Signe Torekov
Collaborating Sponsors:
Hvidovre University Hospital
University of Oxford
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Introduction: The success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after di...
Detailed Description
Obesity is associated with increased risk of developing cardiovascular disease and type 2 diabetes (T2D), along with increased risk of all-cause mortality \[1,2\]. Obesity management guidelines recomm...
Eligibility Criteria
Inclusion
- BMI \> 32 and \< 43 (kg/m2)
- Age \>18 and \<65 years
- Safe contraceptive method
Exclusion
- Patients diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose \> 7 mmol/l)
- Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV)
- Severe renal impairment (creatinine clearance (GFR) \<30 mL/min)
- Severe hepatic impairment
- Inflammatory bowel disease
- Gastroparesis
- Cancer
- Chronic obstructive lung disease
- Psychiatric disease, a history of major depressive or other severe psychiatric disorders
- The use of medications that cause clinically significant weight gain or loss
- Previous bariatric surgery
- A history of idiopathic acute pancreatitis
- A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
- Osteoarthritis which is judged to be too severe to manage the exercise programme. As intended per study design the intervention will include a 5% weight loss prior to randomization, thus it is expected that possible participants with mild form of osteoarthritis will be able to manage exercise prescriptions.
- Pregnancy, expecting pregnancy or breast feeding. If a study participant is in doubt whether she could be pregnant, a urine pregnancy test is performed. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice). Adequate contraception must be used throughout the study period and at least 65 hours after discontinuation of trial medication (65 hours corresponds to 5 times the half-life of Saxenda). Allergy to any of the ingredients/excipients.
- Allergy to any of the ingredients/excipients of the study medication: liraglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide.
- Regular exercise training at high intensity (e.g. spinning) \>2 hours per week.
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT04122716
Start Date
September 1 2016
End Date
November 1 2021
Last Update
November 2 2020
Active Locations (1)
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1
University of Copenhagen, Department of Biomedical Sciences
Copenhagen, Denmark, 2200