Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying
Condition: Obesity
MeSH terms: Obesity
Intervention: Exenatide; Placebo
Intervention description: 5 mcg exenatide subcutaneously twice daily for 30 days; placebo subcutaneously twice daily for 30 days
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese subjects with BMI> 30 Kg/m^2: Otherwise healthy individuals who are not
             currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal,
             hematological, neurological, endocrine (other than hyperglycemia not requiring medical
             therapy) and unstable psychiatric disease.

          -  Women of childbearing potential will have negative pregnancy test before initiation of
             medication.

          -  Gastric emptying (GE): Accelerated GE T1/2 < 79 minutes or GE 1h>35 %

        Exclusion Criteria:

          -  Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes
             Association criteria

          -  Unstable heart disease as evidenced by ongoing angina

          -  Congestive heart failure

          -  Concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or
             orlistat (Xenical®)

          -  Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg)

          -  Use of anti-diabetic drugs including metformin,

          -  History of nephrolithiasis,

          -  Recurrent major depression, presence or history of suicidal behavior or ideation with
             intent to act, and current substantial depressive symptoms (Patient Health
             Questionnaire (PHQ-9) total score ≥10).

          -  Gastroparesis

          -  Inflammatory bowel disease or irritable bowel syndrome

          -  Malignancy treated with chemotherapy within the past 3 years

          -  History of pancreatitis

          -  Renal insufficiency (eGFR less than 50 ml/min)

          -  Concomitant use of monoamine oxidase inhibitors (i.e., phenelzine, selegiline),
             serotonergic agents, and other centrally acting appetite suppressants

          -  Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and
             Depression Scale (HADS) self-administered alcoholism screening test (SAAST, substance
             abuse) and the questionnaire on eating and weight patterns (binge eating disorders and
             bulimia). If such a dysfunction is identified by a HADS score ≥11 in any of the
             subscales or difficulties with substance or eating disorders, the participant will be
             excluded and given a referral letter to his/her primary care doctor for further
             appraisal and follow-up.

          -  Intake of medication that could interfere with the interpretation of the study or
             cause drug interaction (i.e., ketoconazole, erythromycin). Specifically, birth control
             pill, estrogen replacement therapy, and thyroxine replacement are permissible.