This study is being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
Initiate at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6mg/day in weekly intervals to a dose of 3.0 mg/day is achieved (\~4 weeks). Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
Placebo administration will match the study drug.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Gastric Emptying of Solids (T1/2)
The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging.
Time frame: 5 weeks
Gastric Emptying of Solids (T1/2)
The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging.
Time frame: 16 weeks
Change in Weight at 5 Weeks
Change in subject's weight, in kilograms
Time frame: baseline, 5 weeks
Change in Weight at 16 Weeks
Change in subject's weight, in kilograms
Time frame: baseline, 16 weeks
Satiety
Subjects self-reported fullness after eating as much of a prescribed meal measured by kilocalories of food consumed.
Time frame: 16 weeks
Satiation Volume to Fullness
Subjects ingest Ensure 300mL drink meal at a constant rate of 30mL/min until self-reported fullness and volume consumed will be measured in milliliters (mL).
Time frame: 16 weeks
Maximum Satiation
Subjects ingest Ensure 300mL drink meal at a constant rate of 30mL/min until they reach maximum or unbearable fullness. Volume consumed will be measured in milliliters (mL).
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Time frame: 16 weeks
Fasting Gastric Volume Prior to Meal
Gastric fasting volume was measured prior to a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.
Time frame: 16 weeks
Gastric Volume After Meal
Gastric volume was measured after a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.
Time frame: 16 weeks
Gastric Accommodation
Measured in milliliters (mL), using the difference between the fasting gastric volume prior to the meal and the gastric volume after the meal.
Time frame: 16 weeks