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Ghrelin Repeated Dose Study (GRD)

Primary Purpose

Frailty in Aging

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ghrelin
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty in Aging

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

7 day ghrelin dosing - all participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sustainability of Increased Caloric Intake
Sustained food intake of standardized meal from Days 1 compared to Day 7.

Full Information

First Posted
April 11, 2013
Last Updated
September 9, 2015
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01833078
Brief Title
Ghrelin Repeated Dose Study
Acronym
GRD
Official Title
Ghrelin in Frail Elderly Subcutaneous Repeated Dose Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty in Aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
7 day ghrelin dosing - all participants
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ghrelin
Intervention Description
ghrelin administration subcutaneously for 7 days
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals with three, four or five frailty criteria using the Fried frailty criteria Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Cappola, MD, ScM
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Ghrelin Repeated Dose Study

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