Overview

This trial is active, not recruiting.

Condition obesity
Treatments exenatide, placebo
Phase phase 4
Sponsor Mayo Clinic
Start date June 2014
End date October 2016
Trial size 20 participants
Trial identifier NCT02160990, 14-002683 Exenatide

Summary

The overall goal is to determine the effect of Exenatide on gastric emptying, satiety and satiation in obese participants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Qualifying participants will be assigned either Exenatide or or placebo for 30 days.
exenatide
Qualifying participants will be assigned either Exenatide or placebo for 30 days.
(Placebo Comparator)
Qualifying participants will be assigned either placebo or Exenatide for 30 days.
placebo

Primary Outcomes

Measure
The Effect of Exenatide on Gastric Emptying in Obese Participants
time frame: up to 30 days

Secondary Outcomes

Measure
The effect of Exenatide on Gastric Emptying in Obese Participants
time frame: Up to 30 days

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Obese subjects with BMI> 30 Kg/m2: 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. - Age: 18-70 years - Gender: Men or women. Women of childbearing potential will have negative pregnancy test before initiation of medication. - Gastric emptying: 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 behaviour or ideation with intent to act, and current substantial depressive symptoms (Patient Health Questionnaire [PHQ-9]21 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 MAOI 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.

Additional Information

Official title Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying
Principal investigator Michael Camilleri, MD
Description To evaluate the effect of Exenatide 5mcg SQ twice daily for 30-days on gastric emptying, satiety, satiation and weight loss in obese participants with TCF7L2 "CC compared to TT' genotype.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.