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Ghrelin Plus Strength Training in Frail Elderly Study

Primary Purpose

Frailty Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ghrelin
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frailty Syndrome focused on measuring Frailty, Sarcopenia, Weight Loss, Exercise, Aging, Ghrelin, Elderly

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical and Translational Research Center, University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ghrelin plus resistance training

Placebo plus resistance training

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in the Short Physical Performance Battery (SPPB)
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.
Treatment-associated Adverse Events
Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).

Secondary Outcome Measures

Change in Weight
Change in weight from baseline to 12 weeks
Change in Lean Body Mass
Total lean body mass by dual energy x-ray absorptiometry
Change in Muscle Strength
One repetition max bench press
Change in Food Intake
Change in food intake by 3-day food intake record
Change in Quality of Life
Quality of life as assessed by short form 36 (SF-36), higher score indicates better quality of life, scale is 0-100 points
Change in Frailty Status
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

Full Information

First Posted
July 2, 2013
Last Updated
November 26, 2019
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01898611
Brief Title
Ghrelin Plus Strength Training in Frail Elderly Study
Official Title
Ghrelin Plus Strength Training in Frail Elderly Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty Syndrome
Keywords
Frailty, Sarcopenia, Weight Loss, Exercise, Aging, Ghrelin, Elderly

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ghrelin plus resistance training
Arm Type
Active Comparator
Arm Description
Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training
Arm Title
Placebo plus resistance training
Arm Type
Placebo Comparator
Arm Description
Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training
Intervention Type
Drug
Intervention Name(s)
Ghrelin
Intervention Description
Ghrelin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline will be used as a placebo
Primary Outcome Measure Information:
Title
Change in the Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
Baseline to 12 weeks
Title
Treatment-associated Adverse Events
Description
Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Change in Weight
Description
Change in weight from baseline to 12 weeks
Time Frame
Baseline to twelve weeks
Title
Change in Lean Body Mass
Description
Total lean body mass by dual energy x-ray absorptiometry
Time Frame
Baseline to 12 weeks
Title
Change in Muscle Strength
Description
One repetition max bench press
Time Frame
Baseline to 12 weeks
Title
Change in Food Intake
Description
Change in food intake by 3-day food intake record
Time Frame
Baseline to 12 weeks.
Title
Change in Quality of Life
Description
Quality of life as assessed by short form 36 (SF-36), higher score indicates better quality of life, scale is 0-100 points
Time Frame
Baseline to 12 weeks.
Title
Change in Frailty Status
Description
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
Time Frame
Baseline to 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne R. Cappola, M.D.,Sc.M.
Organizational Affiliation
University of Pennsylvania, Perelman School of Medicine, Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Research Center, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5160
Country
United States

12. IPD Sharing Statement

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