Combined Effects of GLP-1 Analogue and Exercise on Maintenance of Weight Loss and Health After Very-low Calorie Diet

Launched by SIGNE TOREKOV · Oct 8, 2019

Keywords

ClinConnect Summary

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 recommends weight loss of more than 5 % of initial body weight to improve cardiometabolic risk factors, with greater weight loss producing greater benefits \[3,4\]. A 5 to 10 % weight loss improves lipid profile (\~20% reduction in triglycerides, \~15 % reduction in LDL-cholesterol, \~8 % increase in HDL-cholesterol levels) \[1,4,5\], reduces systolic and diastolic blood pressure (\~5 and \~4 mmHg, r...

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Eligibility criteria

• Inclusion Criteria:
• • BMI \> 32 and \< 43 (kg/m2)
• • Age \>18 and \<65 years
• • Safe contraceptive method
• Exclusion Criteria:
• • 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.