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Completed

NCT Number: NCT01898611

Ghrelin Plus Strength Training in Frail Elderly Study

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.

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Key information

Conditions

Frailty Syndrome Atrophy Behavior Body Weight Body Weight Changes Frailty Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Weight Loss

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical and Translational Research Center, University of Pennsylvania

Philadelphia, Pennsylvania, 19104-5160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • BMI ≥ 30 kg/m2
  • Current use of corticosteroids other than topical, ophthalmic, and inhaled preparations
  • Therapy with megestrol acetate or dronabinol within the last 6 weeks
  • Thyroid stimulating hormone measured as < 0.4 uIU/L or greater than 10uIU/L
  • Abnormal liver function tests (LFTs > 2x upper limit of normal)
  • Hemoglobin < 11g/dL
  • Insulin-like growth factor-I (IGF-I) above the age-specific reference range
  • History of surgery within the last 30 days
  • Hip fracture of hip or knee replacement within the previous 6 months or unable to walk
  • Deemed unsafe to participate by one of the study exercise therapists
  • Undergoing physical therapy or an exercise program
  • Unstable medical or psychological conditions or unstable home or food environment
  • Cognitive deficit as defined by a Folstein Mini Mental State Exam score < 24/30
  • Depression (defined as a score of > 11 on the Geriatric Depression Questionnaire)
  • Out of town for > 1 week during the 12 week study
  • Residing outside of a 15 mile radius of University of Pennsylvania Health System

Treatment and study plan

Ghrelin

Drug

Ghrelin

Placebo

Drug

Saline will be used as a placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 12, 2013
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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