Status:
COMPLETED
To Predict Weight Loss Response to Liraglutide (Saxenda®), From fMRI-based Determination of Food Cue Reactivity
Lead Sponsor:
Texas Tech University
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The study is a single center, randomized, double blind, placebo controlled; parallel-group repeated measures design. Subjects will be randomly assigned to either Saxenda® or placebo group after baseli...
Eligibility Criteria
Inclusion
- Age 18-60 years
- BMI 30-50 kg/m2
Exclusion
- Participants unable or unwilling to provide informed consent.
- Participants with motor, visual or hearing impairment.
- Females with irregular menstrual cycles (onset of menstruation greater than 1 week from expected data during the last 3 months).
- Females who are currently breastfeeding or intend to start breastfeeding.
- Participants with diagnosed diabetes mellitus (type 1 or type 2) or uncontrolled hypertension, history of ischemic heart disease, stroke, neurological disease.
- Participants with current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression).
- Participants experiencing current suicidal ideation, and recent or past suicide attempts.
- Participants with history of psychiatric hospitalization.
- Participants who are currently on (or have been on within the past 4 weeks) any medication in the broader drug classes of anti-depressant, anti-epileptic, or anti-anxiety medicines will be excluded (as these affect fMRI-FCR in the brain).
- Participants with contraindications for MRI scanning.
- aneurism clips
- any implanted medical devices (pacemaker, neurostimulator)
- known pregnancy
- shrapnel in body or any injury to eye involving metal
- any ferrous metal in body
- Participants with a history of diagnosed eating disorders such as bulimia nervosa, anorexia nervosa and severe binge eating disorder.
- Participants with a history of diagnosed substance abuse or alcohol abuse.
- Patients experiencing persistent loss of appetite, nausea or vomiting within the last 4 weeks without known cause (e.g. flu, food poisoning).
- Participants who have been involved in a weight loss intervention program (including anti-obesity medication) within the past 3 months (and or loss \>10% of body weight) or who have ever had bariatric surgery or have weight loss devices implanted.
- Current smokers (smoked within the last 30 days).
- The receipt of any investigational drug within (3 months) prior to this trial.
- Previous participation in this trial (i.e. randomized).
- Unable or unwilling to consume required study meals for any reason (e.g. dietary restrictions, allergies, or aversions to any of the food items used in the study).
- Contraindications to study medications,
- Subject with a personal or family history of medullary thyroid carcinoma (MTC).
- Subject with multiple endocrine neoplasia syndrome 2 (MEN 2).
- Allergic to Liraglutide or any of the ingredients in Saxenda® (i.e. Active ingredient: liraglutide; Inactive ingredients: disodium phosphate dehydrate, propylene glycol, phenol and water for injection)
- Women who are pregnant, or have the intention of becoming pregnant.
- Taking other GLP-1 receptor agonists (currently or in the past 3 months).
- Current severe problems with stomach, such as slowed emptying of the stomach (gastroparesis) or problems with digesting food.
- Current or past known serious chronic illness of liver, kidney and pancreas.
- Current or recent (30 days) depression or suicidal thoughts.
- Current fasting plasma glucose 126mg/dL or higher or HbA1c 6.5% or higher, or alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) 10% above normal range for the assay.
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03795701
Start Date
January 8 2019
End Date
May 1 2022
Last Update
December 4 2023
Active Locations (2)
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1
Texas Tech Neuroimaging Institute
Lubbock, Texas, United States, 79409
2
Nutrition & Metabolic Health Initiative
Lubbock, Texas, United States, 79410