Completed

Ghrelin Plus Strength Training in Frail Elderly Study

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What is being tested

Ghrelin

+ Placebo

Drug
Who is being recruted

Frailty+13

+ Atrophy

+ Behavior

Over 70 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Placebo-ControlledPhase 2
Interventional
Study Start: July 2013
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

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 investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.

Official TitleGhrelin Plus Strength Training in Frail Elderly Study
NCT01898611
Principal SponsorUniversity of Pennsylvania
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FrailtyAtrophyBehaviorBody WeightBody Weight ChangesMotor ActivityMuscular AtrophyNervous System DiseasesNeurologic ManifestationsPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossPathological Conditions, AnatomicalNeuromuscular ManifestationsSarcopenia

Criteria

1 inclusion criteria required to participate
Individuals with three, four or five frailty criteria using the Fried frailty criteria
20 exclusion criteria prevent from participating
Diabetes mellitus or fasting glucose ≥ 126 mg/dL
Hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months.
New York Heart Association Class III or IV congestive heart failure
Therapy for cancer in the past 12 months, except non-melanoma skin cancer
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training

Group II

Placebo
Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Clinical and Translational Research Center, University of Pennsylvania

Philadelphia, United StatesOpen Clinical and Translational Research Center, University of Pennsylvania in Google Maps
CompletedOne Study Center