Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Exenatide

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.