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Ghrelin Plus Strength Training in Frail Elderly Study

NCT ID: NCT01898611

Last Updated: 2019-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-01

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Frailty Syndrome

Keywords

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Frailty Sarcopenia Weight Loss Exercise Aging Ghrelin Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ghrelin plus resistance training

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

Group Type ACTIVE_COMPARATOR

Ghrelin

Intervention Type DRUG

Ghrelin

Placebo plus resistance training

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline will be used as a placebo

Interventions

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Ghrelin

Ghrelin

Intervention Type DRUG

Placebo

Saline will be used as a placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Individuals with three, four or five frailty criteria using the Fried frailty criteria

Exclusion Criteria

1. Diabetes mellitus or fasting glucose ≥ 126 mg/dL
2. Hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months.
3. New York Heart Association Class III or IV congestive heart failure
4. Therapy for cancer in the past 12 months, except non-melanoma skin cancer
5. BMI ≥ 30 kg/m2
6. Current use of corticosteroids other than topical, ophthalmic, and inhaled preparations
7. Therapy with megestrol acetate or dronabinol within the last 6 weeks
8. Thyroid stimulating hormone measured as \< 0.4 uIU/L or greater than 10uIU/L
9. Abnormal liver function tests (LFTs \> 2x upper limit of normal)
10. Hemoglobin \< 11g/dL
11. Insulin-like growth factor-I (IGF-I) above the age-specific reference range
12. History of surgery within the last 30 days
13. Hip fracture of hip or knee replacement within the previous 6 months or unable to walk
14. Deemed unsafe to participate by one of the study exercise therapists
15. Undergoing physical therapy or an exercise program
16. Unstable medical or psychological conditions or unstable home or food environment
17. Cognitive deficit as defined by a Folstein Mini Mental State Exam score \< 24/30
18. Depression (defined as a score of \> 11 on the Geriatric Depression Questionnaire)
19. Out of town for \> 1 week during the 12 week study
20. Residing outside of a 15 mile radius of University of Pennsylvania Health System
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Anne Cappola

Division of Endocrinology, Diabetes, and Metabolism

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne R. Cappola, M.D.,Sc.M.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania, Perelman School of Medicine, Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism

Locations

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Clinical and Translational Research Center, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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818192

Identifier Type: -

Identifier Source: org_study_id