Ghrelin in Older Women
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Purpose
The purpose of this research study is to see if giving women a hormone called "ghrelin" will increase levels of growth hormone in the blood and increase appetite. Ghrelin is a naturally occurring hormone that is produced mostly by the stomach and causes secretion of another hormone called growth hormone. It also increases short-term appetite and may lower the amount of inflammation in the body.
Some people lose their appetite as they age and have unintentional weight loss. This may be caused by a break in the communication between the stomach and the brain. We are particularly interested in seeing if there is a difference in the effects of ghrelin in older women who have lost weight recently without wanting to and those who have not.
| Condition | Intervention | Phase |
|---|---|---|
|
Frailty |
Drug: ghrelin or saline |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Ghrelin in Healthy and Frail Older Women |
- growth hormone [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- appetite [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- inflammatory markers [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- markers of body weight regulation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | March 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Healthy women
|
Drug: ghrelin or saline
At time 0, an infusion (ghrelin or saline) will be started in one of the IV sites at a dose of 2.5 pmol/kg/min (an equivalent amount of saline will be infused in a stepwise fashion if it is the placebo dose). After 60 minutes, the infusion rate will be increased to 5 pmol/kg/min. After 120 minutes, the ghrelin infusion will be increased again to a dose of 10 pmol/kg/min, and will be continued until 180 minutes, when the infusion will be stopped. will be administered in an identical fashion.
|
|
2
Frail women
|
Drug: ghrelin or saline
At time 0, an infusion (ghrelin or saline) will be started in one of the IV sites at a dose of 2.5 pmol/kg/min (an equivalent amount of saline will be infused in a stepwise fashion if it is the placebo dose). After 60 minutes, the infusion rate will be increased to 5 pmol/kg/min. After 120 minutes, the ghrelin infusion will be increased again to a dose of 10 pmol/kg/min, and will be continued until 180 minutes, when the infusion will be stopped. will be administered in an identical fashion.
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Frail group:
- Women aged 70 or greater
- Able to give informed consent
- Undiagnosed weight loss (>5% over the previous year)
- Two of the following four criteria (from Fried L et al, 2001): low grip strength, slow walking speed, subjective exhaustion, low levels of physical activity
Healthy group:
- Women aged 70 or greater
- Able to give informed consent
- None of the frailty criteria
Exclusion Criteria:
- Prior diagnosis of Parkinson's Disease
- History of cerebrovascular accident with residual hemiparesis
- Hospitalization for treatment of vascular disease (including, coronary heart disease, cerebrovascular disease, peripheral vascular disease) in the past 6 months
- Congestive heart failure
- Rheumatoid arthritis or other inflammatory conditions
- Depression (defined as a score of >11 on the Geriatric Depression Questionnaire)
- History of cancer requiring treatment in the past 5 years, with the exception of cancers which have been cured, or, in the opinion of the investigator, carry a good prognosis
- Cognitive deficit as defined by a Folstein Mini Mental State Exam score < 18/30
- Current use of corticosteroids or immune-modulating agents other than topical, ophthalmic, and inhaled preparations, in past 3 months
- Diabetes mellitus
- TSH measured as <0.5mU/L or greater than 10mU/L. If participant is taking replacement thyroid hormone, they should be on a stable dose for at least 2 months
- History of liver disease or abnormal liver function tests (LFTs > 2x upper limit of normal)
- Renal insufficiency (serum creatinine ≥ 1.4 mg/dL).
- Hemoglobin < 11g/dL
- History of surgery within the last 30 days.
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
- Participation in an investigational drug study within 6 weeks prior to screening visit
- Self reported history of HIV disease
- Hospitalization for chronic obstructive pulmonary disease or asthma in the past 3 months
History of alcohol abuse as defined as any one of the following:
1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24 hr period in the past 12 months; or 3) clinical assessment of alcohol dependence based on two or more positive responses to the CAGE questionnaire (if confirmed by further probing) or on other evidence available to clinic staff. If any of these exclusion criteria are met, the subject may still be considered eligible if, after an explanation of the importance of limiting alcohol intake during the study, the clinic staff believes that the volunteer can and will limit future alcohol intake to acceptable levels.
- History of gastrectomy
- Current therapy with an appetite stimulant, i.e. medroxyprogesterone acetate, within the last 6 weeks.
- Weight >85 kg
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania Clinical and Translational Research Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Anne R Cappola, MD, ScM | University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | Anne R. Cappola, MD, ScM, Assistant Professor of Medicine, University of Pennsylvania School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00520884 History of Changes |
| Other Study ID Numbers: | IRB805400 |
| Study First Received: | August 23, 2007 |
| Last Updated: | May 23, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of Pennsylvania:
|
frailty ghrelin appetite weight loss |
ClinicalTrials.gov processed this record on May 16, 2013