Overview

Semaglutide Use in Elderly Obese Patients

Status:
Not yet recruiting

Trial end date:
2022-12-31

Target enrollment:
0

Participant gender:
All

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 lifestyle and exercise) in elderly obese subjects on body weight and body composition as assessed by DEXA.

Phase:

Phase 4

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

State University of New York at Buffalo

Criteria

Inclusion Criteria:

1. Males and females age: ≥65 years

2. BMI ≥30 Kg/m2 AND waist circumference for women: > 80 cm and for men: > 90 cm

3. Stable body weight (no more than ±3 kg change during the 3 months prior to screening)

4. Able to participate in personalized physical activities and dietary instructions.

5. Participant must be able to read, write, and understand the English language and be
able to provide written consent.

Exclusion Criteria:

1. Current diagnosis of weight changing condition including cancer, gastrointestinal
conditions or eating disorders

2. GLP-1R agonists use within last 6 months

3. Diagnosis of type 1 or 2 diabetes

4. Impaired cognitive function (VA-St. Louis University Mental Survey (VA-SLUMS) score ≤
19)

5. History of chronic/idiopathic acute pancreatitis

6. Personal/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
syndrome type 2

7. Previous surgical treatment for obesity

8. Smoking or use of any nicotine products

9. Use of any medication that could interfere with trial results especially weight
management drugs

10. Anticipated change in lifestyle (e.g., dietary, exercise or sleeping pattern) other
than provided by the study.

11. Hepatic disease or cirrhosis

12. Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN) and/or Alanine
aminotransferase (ALT) > 3X ULN

13. Inability to give informed consent

14. History of gastroparesis

15. History of serious hypersensitivity reaction to these agents

16. Alcoholism

17. Patients with retinopathy

18. Participation in any other concurrent interventional clinical trial -