Ghrelin Dose Finding In Frail Elderly
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ClinicalTrials.gov Identifier: NCT01605435 |
Recruitment Status
:
Completed
First Posted
: May 24, 2012
Last Update Posted
: January 16, 2013
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Condition or disease | Intervention/treatment | Phase |
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The Frailty Syndrome | Drug: Ghrelin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Official Title: | Ghrelin In Frail Elderly Subcutaneous Dose Finding Study |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Ghrelin
Dose finding with each participant receiving placebo and three doses of ghrelin, separated by 3-7 days
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Drug: Ghrelin
The first three participants will receive 2 mcg/kg as a single subcutaneous dose at Visit 3, 5 mcg/kg as a single subcutaneous dose at Visit 4, and 10 mcg/Kg as a single subcutaneous dose at visit 5. There will be 3-10 days between visits. The next three participants will receive either the same dosing at the first three, a regimen that includes an intermediate dose (e.g., 7.5 mcg/kg), or higher (e.g., 12, 15, and 18 mcg/kg) doses.
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- Safety [ Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes ]laboratory measurements compared to placebo (pre- and post-prandial glucose, insulin, free fatty acids, and cortisol).
- Safety [ Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes, 1 day later and through 30 days following the last administration of study treatment. ]Treatment emergent adverse events
- Efficacy [ Time Frame: 2 hours, 30 minutes post injection ]A standardized nutritionally balanced meal provided 30 minutes post injection ) and assessed for caloric intake two hours later based upon returned uneaten portion.
- Growth hormone, total ghrelin and active ghrelin profiles [ Time Frame: 0, 15, 30, 45, 60, 90 and 120 minutes ]
- Food Intake [ Time Frame: Day-1 and Day-2 ]Assessed via self reported food intake record on day 1 and day 2 post injection.

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Ages Eligible for Study: | 70 Years and older (Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- We will include men and women aged 70 or older who are able to provide informed consent and are frail by the Fried criteria (Table 1).
- Table 1. Frailty criteria. Individuals with three, four, or all five criteria are frail.
- Weight loss: Unintentional weight loss of >5% over the previous year
Exhaustion: Two statements are read:
- I felt that everything I did was an effort
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I could not get going. The question is asked "How often in the last week did you feel this way?" 0 = rarely or none of the time (<1 day), 1 = some or a little of the time (1-2 days), 2 = a moderate amount of the time (3-4 days), or 3 = most of the time. A "2" or "3" response to either question is a positive response.
- Low physical activity: Kcal/week of physical activity calculated from the short version of the Minnesota Leisure Time Activity questionnaire.40 < 383 kcals in men or < 270 kcals/wk in women is positive for this criterion.
- Slow walking speed: A usual pace, 15-ft walk timed from a defined standing start. For men ≤173 cm tall and women ≤159 cm, ≥7 sec, and for men >173 cm and women > 159 cm, ≥ 6 sec is positive for this criterion.
- Weakness: Hand grip strength measured with a Jamar dynamometer (Fred Sammons, Inc., Burr Ridge, IL). The average of three measurements performed in the dominant hand is used. For men with BMI ≤ 24 kg/m2, the cutoff is ≤ 29 kg, for BMI 24.1 to 26 the cutoff is ≤ 30 kg, for BMI 26.1 to 28 the cutoff is ≤30 kg, and for BMI > 28 the cutoff is ≤ 32 kg. For women with BMI ≤ 23 kg/m2, the cutoff is ≤ 17 kg, for BMI 23.1 to 26 the cutoff is ≤ 17.3 kg, for BMI 26.1 to 29 the cutoff is ≤ 18 kg, and for BMI > 29 the cutoff is ≤ 21 kg for a positive criterion.
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.
- NYHA 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
- TSH 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 < 18/30
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Depression (defined as a score of >11 on the Geriatric Depression Questionnaire)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605435
United States, Pennsylvania | |
Clinical and Translational Research Center, University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Anne R. Cappola, M.D., Sc.M. | University Of Pennsylvania, Perelman School of Medicine, Department of Endocrinology, Diabetes and Metabolism |
Responsible Party: | Anne Cappola, Associate Professor of Medicine, University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01605435 History of Changes |
Other Study ID Numbers: |
IRB 814309 |
First Posted: | May 24, 2012 Key Record Dates |
Last Update Posted: | January 16, 2013 |
Last Verified: | January 2013 |