Investigators determined to detect the effect of smeglutide on body weight and metabolic indexes among overweight and obese participants through two different dosing programs.
Participants will be randomized into either group. One group will start from 0.25mg per week for four weeks, then increase to 0.5mg per week for four weeks, and 1mg per week maintenance dose for 8 weeks. The other group dosage regime depends on the tolerance of the semaglutide from participants. The dosage will stabilize on the dose how much participant could tolerate. At the end of 16 weeks treatment, comparison will be carried out on weight change before and after treatment and (1) Comparison of different administration methods (standards and titrations) on participant compliance, appetite and quality of life improvement; (2) Comparison of metabolism (waist hip circumference, body fat and body composition, blood pressure, blood lipid, blood glucose, insulin resistance) in different administration modes; (3) Comparison of adverse reactions of metabolic drugs in different administration modes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
treatment with different dosage regimes
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
weight change in kilograms
weight change in kilograms before and after treatment
Time frame: 16 weeks
patient compliance in rate
rate of participants dropout of the study(in percentage)
Time frame: 16 weeks
waist hip circumference in centimeter
waist hip circumference in centimeter
Time frame: 16 weeks
number of adverse events
number of adverse events including hypoglycemia, nausea, vomiting, abdominal pain, diarrhea, constipation, indigestion, burping, flatulence, injection site allergy. Adverse reactions will recorded in percentage (number of participants developed particular adverse reaction divided by all participants in each group, % )
Time frame: 16 weeks
appetite change in score
appetite change measures in appetite questionnaire (visual analogue scales in assessment of appetite sensations, Units on scale is millimeter)
Time frame: 16 weeks
quality of life improvement in score
quality of life improvement (in WHOQOL\~BREF, Units on scale is point);
Time frame: 16 weeks
body fat in percentage
body fat in percentage
Time frame: 16 weeks
body composition of lean mass in kilogram
body composition in kilogram of lean mass
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Time frame: 16 weeks
blood pressure in mmHg
blood pressure in mmHg
Time frame: 16 weeks
blood lipid in concentration
blood lipid in including (total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol in mmol/L),
Time frame: 16 weeks
fasting blood glucose level
fasting blood glucose in milli-mole per liter
Time frame: 16 weeks
HOMA-Beta value
the value of 20 × FINS/(FBG-3.5)
Time frame: 16 weeks
total cholesterol in mmol/L
total cholesterolin mmol/L
Time frame: 16 weeks
triglyceride
triglyceride in mmol/L
Time frame: 16 weeks
low-density lipoprotein cholesterol
low-density lipoprotein cholesterol in mmol/L
Time frame: 16 weeks
high-density lipoprotein cholesterol
high-density lipoprotein cholesterol in mmol/L
Time frame: 16 weeks