Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype

Overview

About this study

The purpose of this study is to evaluate the effect of IC-CBAS 1000 mg BID on EEC function, weight loss, satiety perception, and satiety GI hormones, in patients with APS-OB phenotype. A lifestyle intervention will be provided. These consist of an obesity physician consult, a low-calorie diet instructed by registered dietitians & nutritionists, and physical activity and behavioral suggestions. These interventions should last at least the length of the study. We will include otherwise healthy patients with a BMI > 30, age range 18-65 years, and APS-OB phenotype. Based on the results of our previous trial comparing weight loss in exenatide therapy vs placebo (Acosta, Camilleri, and Burton 2015), we calculated a sample size of 18 participants per group (total of 36) with 80% power, 0.05 alpha to detect a 1 kg difference between treatment and placebo groups.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Willing to provide consent.

- Patients with obesity BMI > 30 kg/m^2 and hungry gut phenotype.

- Gender: men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope for
the gastric emptying study.

- Otherwise healthy individuals or with controlled chronic medical conditions such as type 2 diabetes.

Exclusion Criteria:

- Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening the bowel disease questionnaire will be used to exclude subjects with irritable bowel syndrome.

- Subjects with stool type Bristol classification 6-7 per bowel disease questionnaire.

- Female subjects who are pregnant or breast-feeding.

- Use of anti-obesity medications upon screening (i.e., orlistat, phentermine-topiramate, liraglutide, semaglutide, bupropion-naltrexone), metformin or GLP-1 analogs.

- Individuals who are currently on treatment for unstable cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine, and psychiatric disease.

- Any acute or chronic condition or other disease that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.

- Significant untreated psychiatric dysfunction based upon screening. Hospital Anxiety and - Depression Inventory (HAD) score > 11 on depression scale, a self-administered
alcoholism screening test (AUDIT-C) score >4 in men or >3 in women, and difficulties with substance or eating disorders determined by the Questionnaire on Eating and Weight - Patterns (binge eating disorders and bulimia); will mean the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. The provider will review the patient's alcohol intake over
the past few months to confirm accuracy and determine study eligibility.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Andres Acosta, M.D., Ph.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Andres Acosta, M.D., Ph.D.

Closed for enrollment

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