Ghrelin in Healthy and Frail Older Women

NCT00520884 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IRB805400
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

frailty; ghrelin; appetite; weight loss

Outcome Measures

Primary Outcomes (4)

• Kilocalories Consumed

  Kilocalorie consumption from meal of standardized composition during the visit when infusion complete

  After infusion

• Max Change Growth Hormone

  Maximum growth hormone level change from baseline to 180 minutes

  180 minutes

• Max Change Total Ghrelin

  Maximum total ghrelin change from baseline to 180 minutes

  180 minutes

• Max Change Active Ghrelin

  Active ghrelin change from baseline to 180 minutes. Active ghrelin=acylated ghrelin.

  180 minutes

Study Arms (4)

Healthy 70+ Women Placebo Infusion

PLACEBO COMPARATOR

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.

Other: Placebo Infusion -Healthy

Frail 70+ Women Placebo Infusion

PLACEBO COMPARATOR

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.

Other: Placebo Infusion - Frail

Healthy 70+ Women Ghrelin Infusion

ACTIVE COMPARATOR

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).

Drug: Ghrelin Infusion - Healthy

Frail 70+ Women Ghrelin Infusion

ACTIVE COMPARATOR

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).

Drug: Ghrelin Infusion - Frail

Interventions

Ghrelin Infusion - Healthy DRUG

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.

Also known as: Healthy Older Women Receiving

Healthy 70+ Women Ghrelin Infusion

Ghrelin Infusion - Frail DRUG

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.

Also known as: Frail Older Women Receiving

Frail 70+ Women Ghrelin Infusion

Placebo Infusion -Healthy OTHER

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.

Also known as: Healthy Older Women Receiving

Healthy 70+ Women Placebo Infusion

Placebo Infusion - Frail OTHER

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.

Also known as: Frail Older Women Receiving

Frail 70+ Women Placebo Infusion

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Clinical and Translational Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Frailty; Weight Loss

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Signs and Symptoms

Results Point of Contact

• Title: Anne Cappola, M.D., Sc.M.
• Organization: University of Pennsylvania, Department of Medicine, Division of Endocrinology, Diabetes and Metabolism

ACappola@mail.med.upen.edu

215-573-5359

Study Officials

• Anne R Cappola, MD, ScM

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 27, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 13, 2019
• Results First Posted: June 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)