Ghrelin Plus Strength Training in Frail Elderly Study

NCT01898611 | Completed Phase 2 Results

• 1 other identifier: 818192
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome

Keywords

Frailty; Sarcopenia; Weight Loss; Exercise; Aging; Ghrelin; Elderly

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to 12 weeks

• Treatment-associated Adverse Events

  Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).

  Twelve weeks

Secondary Outcomes (6)

• Change in Weight

  Baseline to twelve weeks

• Change in Lean Body Mass

  Baseline to 12 weeks

• Change in Muscle Strength

  Baseline to 12 weeks

• Change in Food Intake

  Baseline to 12 weeks.

• Change in Quality of Life

  Baseline to 12 weeks.

Study Arms (2)

Ghrelin plus resistance training

ACTIVE COMPARATOR

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

Drug: Ghrelin

Placebo plus resistance training

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ghrelin DRUG

Ghrelin

Ghrelin plus resistance training

Placebo DRUG

Saline will be used as a placebo

Placebo plus resistance training

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Clinical and Translational Research Center, University of Pennsylvania

Philadelphia, Pennsylvania, 19104-5160, United States

Location

MeSH Terms

Conditions

Frailty; Sarcopenia; Weight Loss; Motor Activity

Interventions

Ghrelin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Body Weight Changes; Body Weight; Behavior

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Anne Cappola, MD
• Organization: University of Pennsylvania

acappola@mail.med.upenn.edu

215-573-5359

Study Officials

• Anne R. Cappola, M.D.,Sc.M.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Endocrinology, Diabetes, and Metabolism

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 12, 2013
• Study Start: July 1, 2013
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: December 11, 2019
• Results First Posted: October 11, 2018

Record last verified: 2019-11

Locations

US (1)