Trial · Interventional

CompletedPhase 2Results postedRegistry data

Ghrelin Repeated Dose Study

Short name GRD

NCTNCT01833078Other id817283

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 5 participants (actual)
Sponsor: University of Pennsylvania · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Feb 2013
Primary completion: Jun 2013
Completion: Jun 2013
First posted: 16 Apr 2013 (estimated)
Last update posted: 8 Oct 2015 (estimated)
Conditions: Frailty in Aging

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20132014

Ph 2
GRD
NCT01833078
Feb 2013 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

ghrelinDrug

Arms1

Other
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Safety
Time frame · pre-treatment baseline through 30 days following the last administration of study treatment day 7
Registry description
1.Safety: # of participants with treatment emergent adverse events

Secondary outcomes(1)

Sustainability of Increased Caloric Intake
Time frame · pre-treatment baseline (day 1) through day 7
Registry description
Sustained food intake of standardized meal from Days 1 compared to Day 7.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· pre-treatment baseline through 30 days following the last administration of study treatment day 7

Safety

Group	Value (participants)
Ghrelin	4

Secondary and other outcome results(1)

Secondary outcomeMedian· pre-treatment baseline (day 1) through day 7

Sustainability of Increased Caloric Intake

Group	Value (calories)
Ghrelin	691

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Ghrelinghrelin: ghrelin administration subcutaneously for 7 days	–	0 / 5	4 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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