Ghrelin Plus Strength Training in Frail Elderly Study

Frailty Syndrome Clinical Trial

Official title:

Ghrelin Plus Strength Training in Frail Elderly Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898611
• Other study ID #: 818192
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2013
• Est. completion date: August 31, 2016

Study information

• Verified date: November 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Individuals with three, four or five frailty criteria using the Fried frailty criteria

Exclusion Criteria:

1. Diabetes mellitus or fasting glucose = 126 mg/dL

2. Hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months.

3. New York Heart Association Class III or IV congestive heart failure

4. Therapy for cancer in the past 12 months, except non-melanoma skin cancer

5. BMI = 30 kg/m2

6. Current use of corticosteroids other than topical, ophthalmic, and inhaled preparations

7. Therapy with megestrol acetate or dronabinol within the last 6 weeks

8. Thyroid stimulating hormone measured as < 0.4 uIU/L or greater than 10uIU/L

9. Abnormal liver function tests (LFTs > 2x upper limit of normal)

10. Hemoglobin < 11g/dL

11. Insulin-like growth factor-I (IGF-I) above the age-specific reference range

12. History of surgery within the last 30 days

13. Hip fracture of hip or knee replacement within the previous 6 months or unable to walk

14. Deemed unsafe to participate by one of the study exercise therapists

15. Undergoing physical therapy or an exercise program

16. Unstable medical or psychological conditions or unstable home or food environment

17. Cognitive deficit as defined by a Folstein Mini Mental State Exam score < 24/30

18. Depression (defined as a score of > 11 on the Geriatric Depression Questionnaire)

19. Out of town for > 1 week during the 12 week study

20. Residing outside of a 15 mile radius of University of Pennsylvania Health System

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome

Intervention

Drug:
• Ghrelin
Ghrelin
• Placebo
Saline will be used as a placebo

Locations

Country	Name	City	State
United States	Clinical and Translational Research Center, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Short Physical Performance Battery (SPPB)	The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12.	Baseline to 12 weeks
Primary	Treatment-associated Adverse Events	Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).	Twelve weeks
Secondary	Change in Weight	Change in weight from baseline to 12 weeks	Baseline to twelve weeks
Secondary	Change in Lean Body Mass	Total lean body mass by dual energy x-ray absorptiometry	Baseline to 12 weeks
Secondary	Change in Muscle Strength	One repetition max bench press	Baseline to 12 weeks
Secondary	Change in Food Intake	Change in food intake by 3-day food intake record	Baseline to 12 weeks.
Secondary	Change in Quality of Life	Quality of life as assessed by short form 36 (SF-36), higher score indicates better quality of life, scale is 0-100 points	Baseline to 12 weeks.
Secondary	Change in Frailty Status	According to the Fried frailty criteria: Weight loss, exhaustion, low physical activity, slow walking speed, weakness, range 0 to 5, higher score indicates more frailty	Baseline to 12 weeks.