Ghrelin Repeated Dose Study

NCT01833078 | Completed Phase 2 Results

• 1 other identifier: 817283
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty in Aging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Sustainability of Increased Caloric Intake

  pre-treatment baseline (day 1) through day 7

Study Arms (1)

7 day ghrelin dosing - all participants

OTHER

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.

Drug: ghrelin

Interventions

ghrelin DRUG

ghrelin administration subcutaneously for 7 days

7 day ghrelin dosing - all participants

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diabetes mellitus or fasting glucose ≥ 126 mg/dL
• Hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months.
• New York Heart Association Class III or IV congestive heart failure
• Therapy for cancer in the past 12 months, except non-melanoma skin cancer
• BMI ≥ 30 kg/m2
• Current use of corticosteroids other than topical, ophthalmic, and inhaled preparations
• Therapy with megestrol acetate or dronabinol within the last 6 weeks
• Thyroid stimulating hormone measured as \< 0.4 mU/L or greater than 10mU/L
• Abnormal liver function tests (LFTs \> 2x upper limit of normal)
• Hemoglobin \< 11g/dL
• Insulin-like growth factor-I (IGF-I) above the age-specific reference range
• History of surgery within the last 30 days
• Unstable medical or psychological conditions or unstable home or food environment
• Cognitive deficit as defined by a Folstein Mini Mental State Exam score \< 24/30
• Depression (defined as a score of \> 11 on the Geriatric Depression Questionnaire)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Ghrelin

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Anne Cappola, PI
• Organization: University of Pennsylvania

acappola@mail.med.upenn.edu

215-573-5359

Study Officials

• Anne Cappola, MD, ScM

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Perelman School of Medicine

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 16, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 8, 2015
• Results First Posted: October 8, 2015

Record last verified: 2015-09

Locations

US (1)