Ghrelin Repeated Dose Study

Frailty in Aging Clinical Trial

— GRD  

Official title:

Ghrelin in Frail Elderly Subcutaneous Repeated Dose Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833078
• Other study ID #: 817283
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2013
• Last updated: September 9, 2015
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: September 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 this study, the investigators are trying to find out if repeated daily doses of ghrelin will help frail older people improve food intake for multiple days in a row.

Description:

The study design is an open label, repeated dose administration study in which we will examine the safety and efficacy of repeated subcutaneous ghrelin administration in frail individuals. There will be a screening visit plus three additional study visits at the CTRC on Days 1, 2, and 7. Participants will receive an injection of ghrelin subcutaneously once daily on Days 1 and 7 and will self-administer the subcutaneous injection before breakfast on Days 2-6 at home. A food record will be kept from Day -3 to Day 6. We will assess the efficacy of repeated ghrelin doses to sustainably increase caloric intake from pre-treatment baseline without hyperglycemia or raising of cortisol levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• 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 mU/L or greater than 10mU/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. Unstable medical or psychological conditions or unstable home or food environment

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

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Frailty in Aging

Intervention

Drug:
• ghrelin
ghrelin administration subcutaneously for 7 days

Locations

Country	Name	City	State
United States	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	Safety	1.Safety: # of participants with treatment emergent adverse events	pre-treatment baseline through 30 days following the last administration of study treatment day 7	Yes
Secondary	Sustainability of Increased Caloric Intake	Sustained food intake of standardized meal from Days 1 compared to Day 7.	pre-treatment baseline (day 1) through day 7	No