GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight

Obesity Clinical Trial

Official title:

GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779697
• Other study ID #: 2000027868
• Secondary ID: 2R01DK099039-06
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: Ania Jastreboff, MD, PhD
• Phone: (203) 737-5015
• Email: ania.jastreboff[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• GLP-1 analogue - semaglutide
GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks

Other:
• Placebo
Placebo - administered once weekly for a total of 12 weeks

Locations

Country	Name	City	State
United States	The Yale Stress Center: Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Craving	Craving will be measured using a validated questionnaire called Food Craving Scale (FCS). FCS is an 28-item questionnaire that measures how often participates experienced a craving for a food type. Participants can respond to each item from "never" to "always/ almost every". HIgher scores indicate greater craving.	week 0 and week 12
Primary	Change in Hunger	Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 9. Higher VAS indicates greater hunger.	week 0 and week 12
Primary	Change in Food Intake	Food intake will be measured in KCalories during a validated observed laboratory task	week 0 and week 12
Secondary	Change in weight	Weight in kilograms will be assessed using a bioimpedance scale	weekly for 12 weeks
Secondary	Change in food intake - real-life	Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24)	week 0, 4, 8, 12
Secondary	Change in stress	Stress, measured as total score on the 14-item Perceived Stress Scale, with higher scores indicating greater subjective stress.	week 0, 4, 8, 12