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Ghrelin in Healthy and Frail Older Women

Primary Purpose

Frailty

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ghrelin Infusion - Healthy
Ghrelin Infusion - Frail
Placebo Infusion -Healthy
Placebo Infusion - Frail
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frailty focused on measuring frailty, ghrelin, appetite, weight loss

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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
  • Thyroid stimulating hormone (TSH) measured as <0.5 U/L or greater than 10 U/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 an alcoholism 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

Sites / Locations

  • University of Pennsylvania Clinical and Translational Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Healthy 70+ Women Placebo Infusion

Frail 70+ Women Placebo Infusion

Healthy 70+ Women Ghrelin Infusion

Frail 70+ Women Ghrelin Infusion

Arm Description

Healthy and Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion.

Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion.

Healthy Women 70 and Older are administered a 3 hour graded Ghrelin Infusion (the first hour of the ghrelin infusion a dose of 2.5 pmol/kg/min, increased to a dose of 5.0 pmol/kg/min for one hour, and then increased to the dose of 10 pmol/kg/min for the final hour of the infusion).

Frail Women 70 and Older are administered a 3 hour graded Ghrelin Infusion (the first hour of the ghrelin infusion at a dose of 2.5 pmol/kg/min, increased to a dose of 5.0 pmol/kg/min for one hour, and then increased to the dose of 10 pmol/kg/min for the final hour of the infusion).

Outcomes

Primary Outcome Measures

Kilocalories Consumed
Kilocalorie consumption from meal of standardized composition during the visit when infusion complete
Max Change Growth Hormone
Maximum growth hormone level change from baseline to 180 minutes
Max Change Total Ghrelin
Maximum total ghrelin change from baseline to 180 minutes
Max Change Active Ghrelin
Active ghrelin change from baseline to 180 minutes. Active ghrelin=acylated ghrelin.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2007
Last Updated
May 21, 2019
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00520884
Brief Title
Ghrelin in Healthy and Frail Older Women
Official Title
A Pilot Study of Ghrelin in Healthy and Frail Older Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Five community-dwelling women aged 70 or over with unintentional weight loss of >5% in the prior year plus at least 2 of the 4 remaining Fried criteria for frailty and five healthy women without any frailty criteria were enrolled. Women with conditions that can cause weight loss or taking an appetite stimulant or corticosteroids were excluded. Each woman completed two 180 minute infusions, one week apart, assigned randomly: a graded ghrelin infusion of 2.5, 5.0, and 10.0 pmol/kg/min for 60 minutes each and an equivalent placebo (saline) infusion. A meal of standardized composition was provided after each infusion and intake quantified. Samples were collected every 30 minutes for growth hormone (GH), and total and active ghrelin. Additional samples were collected every 60 minutes for glucose, insulin, free fatty acids, leptin, adiponectin, resistin, glucagon-like peptide-1 receptor agonists (GLP-1), and cortisol. Adverse events were collected during the infusion and by telephone 24 hours later. Non-parametric methods were used to compare differences in response to the ghrelin and placebo infusions 1) in all women and 2) between frail and healthy women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
frailty, ghrelin, appetite, weight loss

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy 70+ Women Placebo Infusion
Arm Type
Placebo Comparator
Arm Description
Healthy and Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion.
Arm Title
Frail 70+ Women Placebo Infusion
Arm Type
Placebo Comparator
Arm Description
Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion.
Arm Title
Healthy 70+ Women Ghrelin Infusion
Arm Type
Active Comparator
Arm Description
Healthy Women 70 and Older are administered a 3 hour graded Ghrelin Infusion (the first hour of the ghrelin infusion a dose of 2.5 pmol/kg/min, increased to a dose of 5.0 pmol/kg/min for one hour, and then increased to the dose of 10 pmol/kg/min for the final hour of the infusion).
Arm Title
Frail 70+ Women Ghrelin Infusion
Arm Type
Active Comparator
Arm Description
Frail Women 70 and Older are administered a 3 hour graded Ghrelin Infusion (the first hour of the ghrelin infusion at a dose of 2.5 pmol/kg/min, increased to a dose of 5.0 pmol/kg/min for one hour, and then increased to the dose of 10 pmol/kg/min for the final hour of the infusion).
Intervention Type
Drug
Intervention Name(s)
Ghrelin Infusion - Healthy
Other Intervention Name(s)
Healthy Older Women Receiving
Intervention Description
At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped.
Intervention Type
Drug
Intervention Name(s)
Ghrelin Infusion - Frail
Other Intervention Name(s)
Frail Older Women Receiving
Intervention Description
At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min will be infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped.
Intervention Type
Other
Intervention Name(s)
Placebo Infusion -Healthy
Other Intervention Name(s)
Healthy Older Women Receiving
Intervention Description
At time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped.
Intervention Type
Other
Intervention Name(s)
Placebo Infusion - Frail
Other Intervention Name(s)
Frail Older Women Receiving
Intervention Description
At time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped.
Primary Outcome Measure Information:
Title
Kilocalories Consumed
Description
Kilocalorie consumption from meal of standardized composition during the visit when infusion complete
Time Frame
After infusion
Title
Max Change Growth Hormone
Description
Maximum growth hormone level change from baseline to 180 minutes
Time Frame
180 minutes
Title
Max Change Total Ghrelin
Description
Maximum total ghrelin change from baseline to 180 minutes
Time Frame
180 minutes
Title
Max Change Active Ghrelin
Description
Active ghrelin change from baseline to 180 minutes. Active ghrelin=acylated ghrelin.
Time Frame
180 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Thyroid stimulating hormone (TSH) measured as <0.5 U/L or greater than 10 U/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 an alcoholism 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne R Cappola, MD, ScM
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Clinical and Translational Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ghrelin in Healthy and Frail Older Women

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