Primary outcomeNumber· 30 days following the last administration of study treatment.
Treatment Emergent Adverse Events
| Group | Value (Events) |
|---|---|
| Placebo | 1 |
| 2ug/kg | 0 |
| 5ug/kg | 1 |
| 7.5ug/kg | 0 |
| 10ug/kg | 0 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataGhrelin Dose Finding In Frail Elderly
NCTNCT01605435 (opens ClinicalTrials.gov in a new tab)Other idIRB 814309
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 5 participants (actual)
- Sponsor
- University of Pennsylvania · Other
- Design
- Not randomized · Single masking
- Countries
1 country
United States
- Start
- May 2012
- Primary completion
- Dec 2012
- Completion
- Dec 2012
- First posted
- 24 May 2012 (estimated)
- Last update posted
- 12 Dec 2019
- Conditions
- The Frailty Syndrome
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20122013
- Ph 2
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 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.
Interventions
- Ghrelin Group 1Drug
- Ghrelin Group 2Drug
Arms2
Experimental
Ghrelin Group 1
Dose finding with each of the first two participant coming to the CTRC for four visits greater than or equal to 72 hours apart and on each receiving subcutaneous injection of - placebo (first visit) and three escalating doses of ghrelin 2ug/kg (second visit) , 5 ug/kg (third visit), and 10 ug/kg (fourth visit).
Experimental
Ghrelin Group 2
Dose finding with each of the final three participant coming to the CTRC for four visits greater than or equal to 72 hours apart and on each receiving subcutaneous injection of - placebo (first visit) and three escalating doses of ghrelin 5ug/kg (second visit) , 7.5 ug/kg (third visit), and 10 ug/kg (fourth visit).
Primary outcomes8
Outcomes the sponsor listed as primary.
Treatment Emergent Adverse Events
Time frame · 30 days following the last administration of study treatment.
Registry description
Number and type of treatment emergent adverse events
Median Energy Intake
Time frame · 30 mins post-ghrelin or placebo
Registry description
Median energy intake at breakfast, which was served 30 minutes post-placebo or ghrelin administration demonstrated at each dose level.
Percentage of Total Energy Intake Relative to Placebo
Time frame · 30 mins post-ghrelin or placebo
Registry description
% of total energy relative to placebo - breakfast served 30 minutes post-placebo or ghrelin administration.
Growth Hormone
Time frame · 30 minutes after ghrelin administration
Registry description
median growth hormone peak 30 minutes after placebo/ghrelin.
Cortisol Level
Time frame · 0, 60 and 120 minutes after dosing
Registry description
Cortisol response to ghrelin or placebo - levels at 0, 60 and 120 minutes after dosing
Glucose Levels
Time frame · 0 minutes (baseline) and 60 or 90 minutes from dosing
Registry description
Median fasting and peak postprandial Glucose levels (60 or 90 minutes from dosing) at placebo and at each ghrelin dose.
Insulin Level
Time frame · 0 and 90 minutes after dosing
Registry description
Median fasting insulin levels at baseline and 90 minutes after dosing
Free Fatty Acid Level
Time frame · 90 and 120 minutes after dosing
Registry description
Free Fatty Acid levels (mEq/L) at 60 and 90 minutes after meal (90 and 120 minutes)
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 outcomeMedian· 30 mins post-ghrelin or placebo
Median Energy Intake
| Group | Value (Kilocalories) |
|---|---|
| Placebo | 535.16 |
| 2 mcg/kg | 578 |
| 5mcg/kg | 813 |
| 7.5mcg/kg | 852 |
| 10mcg/kg | 862.04 |
Primary outcomeNumber· 30 mins post-ghrelin or placebo
Percentage of Total Energy Intake Relative to Placebo
| Group | Value (percentage of placebo intake) |
|---|---|
| Placebo | 100 |
| 2 mcg/kg | 110 |
| 5mcg/kg | 135 |
| 7.5mcg/kg | 139 |
| 10mcg/kg | 129 |
Primary outcomeMedian· 30 minutes after ghrelin administration
Growth Hormone
| Group | Value (ng/mL) |
|---|---|
| Placebo | 3.71 |
| 2mcg/kg | 16.87 |
| 5mcg/kg | 31.81 |
| 7.5mcg/kg | 39.20 |
| 10mcg/kg | 33.63 |
Primary outcomeMedian· 0, 60 and 120 minutes after dosing
Cortisol Level
| Group | Value (mcg/dL) |
|---|---|
| Placebo | 26.4 |
| 2ug/kg | 27.1 |
| 5ug/kg | 28.4 |
| 7.5ug/kg | 21.5 |
| 10ug/kg | 22.7 |
Primary outcomeMedian· 0 minutes (baseline) and 60 or 90 minutes from dosing
Glucose Levels
| Group | Value (mg/dL) |
|---|---|
| Placebo | 93 |
| 2mcg/kg | 90 |
| 5mcg/kg | 91 |
| 7.5mcg/kg | 104 |
| 10mcg/kg | 94 |
Primary outcomeMedian· 0 and 90 minutes after dosing
Insulin Level
| Group | Value (uIU/mL) |
|---|---|
| Placebo | 12.9 |
| 2ug/kg | 14.8 |
| 5ug/kg | 8.5 |
| 7.5ug/kg | 8.7 |
| 10ug/kg | 9.7 |
Primary outcomeMedian· 90 and 120 minutes after dosing
Free Fatty Acid Level
| Group | Value (mEq/L) |
|---|---|
| Placebo | 0.17 |
| 2mcg/kg | 0.11 |
| 5mcg/kg | 0.22 |
| 7.5mcg/kg | 0.35 |
| 10mcg/kg | 0.29 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboVisit 1 for all five subjects placebo injected s.c. at time 0 | – | 0 / 5 | 2 / 5 |
| 2mcg/kgVisit 2 for the first two subjects 2mcg/kg ghrelin injected s.c at time 0 | – | 0 / 2 | 0 / 2 |
| 5mcg/kgVisit 3 for the first two subjects Visit 2 for the last three subjects 5mcg/kg ghrelin injected s.c. at time 0 | – | 0 / 5 | 1 / 5 |
| 7.5mcg/kgVisit 3 for the last three subjects 7.5mcg/kg ghrelin injected at time 0 | – | 0 / 3 | 3 / 3 |
| 10mcg/kgVisit 4 for all five subjects | – | 0 / 5 | 1 / 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:
* 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 (\<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 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:
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. NYHA 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. TSH 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 \< 18/30
15. Depression (defined as a score of \>11 on the Geriatric Depression Questionnaire)
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