Status:
COMPLETED
Semaglutide Use in Elderly Obese Patients
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Obesity
Aging
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
This is a single-center, prospective, controlled, randomized and open label study to investigate the effect of the semaglutide addition to standard of care weight loss intervention (personalized lifes...
Detailed Description
This will be a single center, prospective, open label, randomized and controlled pilot study to investigate the effects of semaglutide addition to a standard weight loss intervention program for 16 we...
Eligibility Criteria
Inclusion
- Males and females age: ≥65 years
- BMI ≥30 Kg/m2 AND waist circumference for women: \> 80 cm and for men: \> 90 cm
- Stable body weight (no more than ±3 kg change during the 3 months prior to screening)
- Able to participate in personalized physical activities and dietary instructions.
- Participant must be able to read, write, and understand the English language and be able to provide written consent.
Exclusion
- Current diagnosis of weight changing condition including cancer, gastrointestinal conditions or eating disorders
- GLP-1R agonists use within last 6 months
- Diagnosis of type 1 or 2 diabetes
- Impaired cognitive function (VA-St. Louis University Mental Survey (VA-SLUMS) score ≤ 19)
- History of chronic/idiopathic acute pancreatitis
- Personal/family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Previous surgical treatment for obesity
- Smoking or use of any nicotine products
- Use of any medication that could interfere with trial results especially weight management drugs
- Anticipated change in lifestyle (e.g., dietary, exercise or sleeping pattern) other than provided by the study.
- Hepatic disease or cirrhosis
- Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) \> 3X ULN
- Inability to give informed consent
- History of gastroparesis
- History of serious hypersensitivity reaction to these agents
- Alcoholism
- Patients with retinopathy
- Participation in any other concurrent interventional clinical trial -
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05302596
Start Date
September 1 2022
End Date
October 30 2024
Last Update
April 17 2025
Active Locations (1)
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1
Diabetes and Endocrinology Research Center
Buffalo, New York, United States, 14221