Individualized Obesity Pharmacotherapy



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:12/17/2017
Start Date:December 11, 2017
End Date:December 1, 2020

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Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial

The researchers are trying to identify the specific characteristics (phenotypes) that may be
useful to help select the right medication for weight loss.

All participants will be phenotype and participants will randomized to randomly assigned
medications vs phenotype guided medications for obesity. All participants will receive a
standard intense lifestyle intervention.All participants will be seen at 4 and 12 weeks. At
the 12-week visit, participants will be unblinded to their "obesity-related phenotype" and
they could contact their physician to continue a FDA-approved medication as part of clinical
care. Study team will prospectively follow the patients' weight, waist circumference and use
of obesity medications every 3 months for 1 year.

Inclusion criteria:

- Adults with obesity (BMI >30 Kg/m2); these will be otherwise healthy individuals with
no unstable psychiatric disease and controlled comorbidities or other diseases.

- Gender: Men or women. Women of childbearing potential will have negative pregnancy
tests within 48 hours of enrollment and before each radiation exposure.

Exclusion criteria

- Abdominal bariatric surgery

- Positive history of chronic gastrointestinal diseases, or systemic disease that could
affect gastrointestinal motility, or use of medications that may alter
gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6
months.

- Significant untreated psychiatric dysfunction based upon screening with the Hospital
Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight
Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by
an anxiety or depression score >11 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.

- Hypersensitivity to any of the study medications.

- No contraindications to all FDA-approved medications
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Andres J Acosta
Phone: 507-266-9447
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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