Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall goal of this study was to determine the effect of exenatide on gastric emptying,
      satiety and satiation in obese participants. The hypothesis in this study was that exenatide
      retards gastric emptying in obese patients with baseline accelerated gastric emptying.
    

Detailed description: 
      This study evaluated the effect of exenatide 5mcg subcutaneous (SQ) twice daily for 30-days
      versus placebo on gastric emptying, satiety, satiation and weight loss in obese participants
      with documented accelerated gastric emptying of solids.

      Visit 1: Screening - physical exam, questionnaires, pregnancy test. Participants were
      instructed to continue on the same diet and exercise routine during the entire study.

      Visit 2: Satiation Study Day - Subjects returned to the clinic after after fasting for at
      least 8 hours. A baseline satiation/nutrient drink test was performed on Day 0 prior to
      initiation of exenatide or placebo. The satiation/nutrient drink test involved drinking a
      liquid meal (Ensure) at a rate of one ounce per minute until no more could be ingested. At
      the same time, subject's symptoms were recorded while they drank the liquid meal and for 30
      minutes after they reached the maximum volume tolerated. Subjects were randomized to
      exenatide or placebo, then received 30 days' supply of blinded study medication.

      Visit 3: Satiation Study Day - (This test was performed in the last 5 days of the 30 days of
      medication administration.) Subjects returned to the clinic after after fasting for at least
      8 hours. Subjects were instructed to inject exenatide or placebo 30 minutes before the start
      of the satiation/nutrient drink test. The satiation/nutrient drink test was repeated.

      Visit 4: Gastric Emptying by Scintigraphy Day - (This test was performed in the last 5 days
      of the 30 days of medication administration.) Subjects returned to the clinic after after
      fasting for at least 8 hours. Subjects were instructed to inject exenatide or placebo 30
      minutes before the start of the gastric emptying test. Subjects were given a scrambled egg
      breakfast with toast and a glass of milk. The eggs contain a small amount of radioactive
      substance. At the completion of the breakfast test meal, subjects were instructed to stand in
      front of a special camera and pictures were taken at specific intervals. On the same day,
      subjects participated in an all you can eat meal. This meal consists of lasagna, pudding, and
      skim milk. Food containers were weighed after the meal and calories consumed were estimated
      using validated dietary software.
    

Intervention name(s): Exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mcg exenatide subcutaneously twice daily for 30 days; placebo subcutaneously twice daily for 30 days
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity