Phase 2
N=5
Ghrelin Dose Finding In Frail Elderly
The Frailty Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01605435 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Treatment Emergent Adverse Events — 1; 0; 1; 0 Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ghrelin Group 1 (Drug); Ghrelin Group 2 (Drug)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Emergent Adverse Events |
1; 0; 1; 0; 0; 0 | — |
| PRIMARY Median Energy Intake |
535.16; 578; 813; 852; 862.04 | — |
| PRIMARY Percentage of Total Energy Intake Relative to Placebo |
100; 110; 135; 139; 129 | — |
| PRIMARY Growth Hormone |
3.71; 16.87; 31.81; 39.20; 33.63 | — |
| PRIMARY Cortisol Level |
26.4; 27.1; 28.4; 21.5; 22.7; 18.6 | — |
| PRIMARY Glucose Levels |
93; 90; 91; 104; 94; 142 | — |
| PRIMARY Insulin Level |
12.9; 14.8; 8.5; 8.7; 9.7; 82.9 | — |
| PRIMARY Free Fatty Acid Level |
0.17; 0.11; 0.22; 0.35; 0.29; 0.10 | — |
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 purpose of this study is to determine the optimal subcutaneous ghrelin dose as a potential intervention for frail elderly individuals. We will examine food intake and metabolic parameters after placebo and ghrelin administration at three escalating subcutaneously administered doses.
Eligibility Criteria
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
- 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 ( 173 cm and women > 159 cm, ≥ 6 sec is positive for this criterion.
- Weakness: Hand grip strength measured with a dynamometer. 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 2x upper limit of normal)
- Hemoglobin 11 on the Geriatric Depression Questionnaire)
-
Data sourced from ClinicalTrials.gov (NCT01605435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.