Ghrelin Repeated Dose Study

NCT ID: NCT01833078

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-06-30

Brief 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.

Detailed 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.

Conditions

Frailty in Aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

7 day ghrelin dosing - all participants

All participants will receive an injection of ghrelin (7.5mcg/kg) dose subcutaneously once daily on Days 1, 2 and 7 in the research center and will self-administer the subcutaneous injection before breakfast on Days 2-6 at home.

Group Type: OTHER

ghrelin

Intervention Type: DRUG

ghrelin administration subcutaneously for 7 days

Interventions

ghrelin

ghrelin administration subcutaneously for 7 days

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Anne Cappola

Associate Professor of Medicine, Perelman School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Cappola, MD, ScM

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

817283

Identifier Type: -

Identifier Source: org_study_id