GRD: Ghrelin Repeated Dose Study

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01833078
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 3.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty in Aging	Drug: ghrelin	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ghrelin in Frail Elderly Subcutaneous Repeated Dose Study
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: ghrelin; ghrelin administration subcutaneously for 7 days

Outcome Measures

Primary Outcome Measures

1. Safety [pre-treatment baseline through 30 days following the last administration of study treatment day 7]

   1.Safety: # of participants with treatment emergent adverse events

Secondary Outcome Measures

1. Sustainability of Increased Caloric Intake [pre-treatment baseline (day 1) through day 7]

   Sustained food intake of standardized meal from Days 1 compared to Day 7.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Anne Cappola, MD, ScM, University of Pennsylvania Perelman School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne Cappola, Associate Professor of Medicine, Perelman School of Medicine, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01833078
• Other Study ID Numbers: 817283
• First Posted: Apr 16, 2013
• Last Update Posted: Oct 8, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Frailty

Study Results

Participant Flow

Recruitment Details	Participants were recruited from the outpatient medical practice serving the geriatric population at University of Pennsylvania via an electronic alert to physicians. Ten subjects were screened in order to obtain five eligible participants.

Arm/Group Title	Ghrelin
Arm/Group Description	All participants received 7.5 mcg/kg of ghrelin as a once daily subcutaneous dose for seven consecutive days. Days 1, 2 and 7 will be in the research center. Days 3,4,5,and 6 will be self administered at home.
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Ghrelin
Arm/Group Description	ghrelin: ghrelin administration subcutaneously for 7 days
Overall Participants	5
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	86
Sex: Female, Male (Count of Participants)
Female	1 20%
Male	4 80%
Region of Enrollment (participants) [Number]
United States	5 100%

Outcome Measures

1. Primary Outcome

Title	Safety
Description	1.Safety: # of participants with treatment emergent adverse events
Time Frame	pre-treatment baseline through 30 days following the last administration of study treatment day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ghrelin
Arm/Group Description	ghrelin: ghrelin administration subcutaneously for 7 days
Measure Participants	5
Number [participants]	4 80%

2. Secondary Outcome

Title	Sustainability of Increased Caloric Intake
Description	Sustained food intake of standardized meal from Days 1 compared to Day 7.
Time Frame	pre-treatment baseline (day 1) through day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ghrelin
Arm/Group Description	ghrelin: ghrelin administration subcutaneously for 7 days
Measure Participants	5
Baseline (day 1)	691
Day 7	839

Adverse Events

Time Frame	Study enrollment through one month following the final visit.
Arm/Group Title	Ghrelin
Arm/Group Description	ghrelin: ghrelin administration subcutaneously for 7 days
All Cause Mortality
	Ghrelin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ghrelin
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Ghrelin
	Affected / at Risk (%)	# Events
Total	4/5 (80%)
Gastrointestinal disorders
mild diarrhea	1/5 (20%)
mild and transient abdominal discomfort, rumbling and flatulance	1/5 (20%)
General disorders
tired	2/5 (40%)
mild and transient headache	1/5 (20%)
transient feeling of pronounced heartbeat	1/5 (20%)
Mild fatigue	2/5 (40%)
feeling of laziness	1/5 (20%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.