A Study of the Effect of Liraglutide on Weight Loss and Stomach Functions in Obesity

Overview

About this study

Obesity is associated with differences in stomach function, feeling of fullness after meals, and total calories consumed at a buffet meal. Based upon previous research, our study hypothesis is that weight loss with pharmacological agents may be individualized, based on the abnormality in those gastrointestinal functions. These studies will provide support for the principle that specific obesity medications should be selected according to individual characteristics, and it is anticipated that this approach will enhance the effectiveness of medication treatment of obesity.

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:

  • Overweight and obese adults (≥30 kg/m2 or ≥27 kg/m2 with an obesity-related co-morbidity).
  • Subjects will reside within 125 miles of Mayo Clinic in Rochester, Minnesota.
  • Healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia type 2 diabetes mellitus on metformin) disorders.
  • Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrolment and before each radiation exposure.
  • Subjects must have the ability to provide informed consent before any trial-related activities.

Exclusion Criteria:

  • Weight exceeding 137 kilograms (safety limit of camera for measuring gastric volumes).
  • Abdominal surgery other than appendectomy, Caesarian section or tubal ligation.
  • Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat.
  • Patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia-type 2.
  • Patients with a personal history of pancreatitis (acute or chronic)
  • Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory, a self-administered alcoholism screening test (AUDIT-C), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a Hospital Anxiety Depression (HAD) score >8 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, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxin replacement therapy and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility including gastric emptying (GE) and gastric accommodation. For example, statins for hyperlipidemia, diuretics, β-adrenergic blockers,Angiotensin Converting Enzyme (ACE) inhibitors and angiotensin antagonists for hypertension, and metformin for type 2 diabetes mellitus or prediabetes are permissible. In contrast, resin sequestrants for hyperlipidemia [which may reduce GE and reduce appetite, α2-adrenergic agonists for hypertension, or other GLP-1 receptor agonists (exenatide) or amylin analogs (pramlintide) are not permissible because they significantly affect GE and/or gastric accommodation.
  • Hypersensitivity to the study medication, liraglutide.

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Closed for enrollment

Contact information:

Deborah Eckert R.N.

(507)538-5860

Eckert.Deborah@mayo.edu

More information

Publications

  • Liraglutide, a long-acting GLP-1 receptor agonist, is approved for treatment of obesity; however, the mechanisms of action of liraglutide are incompletely understood. We compared effects of liraglutide versus placebo on gastric motor functions, satiation, satiety, and weight in obese individuals over 16 weeks. Read More on PubMed
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