Ghrelin in Older Women

This study has been completed.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00520884
First received: August 23, 2007
Last updated: May 23, 2011
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • growth hormone [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520884

Locations
United States, Pennsylvania
University of Pennsylvania Clinical and Translational Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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 October 20, 2014