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Ghrelin Plus Strength Training in Frail Elderly Study

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ClinicalTrials.gov Identifier: NCT01898611
Recruitment Status : Completed
First Posted : July 12, 2013
Results First Posted : October 11, 2018
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Anne Cappola, University of Pennsylvania

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Frailty Syndrome Drug: Ghrelin Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Ghrelin Plus Strength Training in Frail Elderly Study
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : August 31, 2016
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ghrelin plus resistance training
Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training
 Drug: Ghrelin
Ghrelin
Placebo Comparator: Placebo plus resistance training
Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training
 Drug: Placebo
Saline will be used as a placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in the Short Physical Performance Battery (SPPB) [ Time Frame: Baseline to 12 weeks ]
    The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12.

  2. Treatment-associated Adverse Events [ Time Frame: Twelve weeks ]
    Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).


Secondary Outcome Measures :
  1. Change in Weight [ Time Frame: Baseline to twelve weeks ]
    Change in weight from baseline to 12 weeks

  2. Change in Lean Body Mass [ Time Frame: Baseline to 12 weeks ]
    Total lean body mass by dual energy x-ray absorptiometry

  3. Change in Muscle Strength [ Time Frame: Baseline to 12 weeks ]
    One repetition max bench press

  4. Change in Food Intake [ Time Frame: Baseline to 12 weeks. ]
    Change in food intake by 3-day food intake record

  5. Change in Quality of Life [ Time Frame: Baseline to 12 weeks. ]
    Quality of life as assessed by short form 36 (SF-36), higher score indicates better quality of life, scale is 0-100 points

  6. Change in Frailty Status [ Time Frame: Baseline to 12 weeks. ]
    According to the Fried frailty criteria: Weight loss, exhaustion, low physical activity, slow walking speed, weakness, range 0 to 5, higher score indicates more frailty


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898611


Locations
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United States, Pennsylvania
Clinical and Translational Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-5160
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Anne R. Cappola, M.D.,Sc.M. University of Pennsylvania, Perelman School of Medicine, Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism
More Information
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Responsible Party: Anne Cappola, Division of Endocrinology, Diabetes, and Metabolism, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01898611    
Other Study ID Numbers: 818192
First Posted: July 12, 2013    Key Record Dates
Results First Posted: October 11, 2018
Last Update Posted: December 11, 2019
Last Verified: November 2019
Keywords provided by Anne Cappola, University of Pennsylvania:
Frailty
Sarcopenia
Weight Loss
Exercise
 Aging
Ghrelin
Elderly
Additional relevant MeSH terms:
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Frailty
Pathologic Processes