Obesity
Conditions
Brief summary
To examine response to a glucagon-like peptide-1 analogue vs. placebo in patients with obesity and assess impact on craving, hunger, stress, and weight outcomes.
Detailed description
A randomized, double-blind, placebo-controlled 12-week study with GLP-1 analogue (semaglutide) in men and women with obesity (BMI 30-49.9 kg/m2) in a validated laboratory model to identifying processes underlying greater food craving, intake and weight change, in order to test mechanisms by which a GLP-1 analogues may exerts significant weight effects in obesity.
Interventions
DRUGGLP-1 analogue - semaglutide
GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
OTHERPlacebo
Placebo - administered once weekly for a total of 12 weeks
Sponsors
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* BMI ranging from 30-49.9 kg/m2 * No significant medical problems, including diabetes * No history of HgbA1c \<6.5% * English speaking and able to read English and complete study evaluations * Able to provide informed written and verbal consent
Exclusion criteria
* Any significant current medical conditions, including neurological, renal, thyroid, cardiovascular, liver, endocrine or immune conditions, including diagnosis of T2DM or T1DM by American Diabetes Association (ADA) criteria * Meet current or past DSM-IVR criteria for alcohol dependence or any substance use disorders, including nicotine, or psychiatric disorders, including eating disorders, or use of any psychiatric medications, including anxiolytics, antidepressants, naltrexone or antabuse, anti-smoking medications * Current active participation in a weight loss program or weight loss of \>10% of total body weight during the prior 6 months * Taking any other anti-obesity medication * History of pancreatitis, medullary thyroid cancer, or MEN syndrome, or (6) women who are pregnant or lactating, or peri/postmenopausal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Craving Score | Average change in avg FCI craving score from week 0 to end of treatment (week 12) computed as avg FCI score at week 12 - avg FCI score at Week 0. | Change in craving score will be measured using a validated and revised questionnaire called Food Craving Inventory (FCI-R). FCI-R is an 28-item questionnaire that measures how often participants experienced specific food cravings for each of 28 different food types. Participants can respond to each item from "not at all" (score=1) to "more than ever" (score=5), with total FCI-R score range of 28-140. Higher mean scores indicate greater average food craving. A negative change indicates a decrease in craving with treatment. |
| Change in Hunger Score | Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS) | Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 10. Higher VAS indicates greater hunger. Negative change in score indicates less hunger with treatment. |
| Change in Food Intake | Change in FST total calorie energy density (totalcalED)from FST at week 0 and FST during treatment at week 12 (week 12 FST - Week 0 FST totalcalED change) | Food intake will be measured in total calorie energy density during a validated observed laboratory task called the Food Snack Test (FST).Negative change indicates a lower food intake with treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Food Intake - Real-World | Average change from baseline to end of treatment (Kcalories at week 12 - week 0) | Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24). A negative change indicates lower food intake with treatment. |
| Change in Stress Score | Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0) | Stress, measured as total summed score on the 14-item Perceived Stress Scale, with higher scores indicating greater subjective stress. A negative change indicates lower stress with treatment. The Perceived Stress Scale (PSS)-14 has a total score range of 0 to 56, with individual items scored from 0 ("Never") to 4 ("Very often") and positively worded items reverse-scored before summing. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnia Jastreboff, MD, PhD
Internal Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology);
PRINCIPAL_INVESTIGATORRajita Sinha, PhD
Psychiatry; Director Yale Stress Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 8.7 |
| Baseline Body Mass Index (BMI) | 37.3 kg/m^2 STANDARD_DEVIATION 4.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 86 participants |
| Regularly Use Substances No | 22 Participants |
| Regularly Use Substances Yes | 13 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 13 Participants |
| Years of Education | 16.4 years STANDARD_DEVIATION 2.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 39 / 48 | 32 / 48 |
| serious Total, serious adverse events | 1 / 48 | 0 / 48 |
Outcome results
None listed