NCT01410799

Brief Summary

The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH and improve these body tissues. Healthy men and women age 65 and older will receive GHRH in four doses nightly for 12 weeks and assessed for changes in muscle strength, body mass, physical performance, and how the body uses sugar.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2011

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

May 24, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

June 17, 2011

Results QC Date

April 25, 2019

Last Update Submit

May 23, 2019

Conditions

Hormone DeficiencyAging

Keywords

Growth Hormone Releasing HormoneGrowth Hormone InsufficiencyAgingGrowth HormonePhysiologic Effects of DrugsHormones, Hormone Substitutes, and Hormone AntagonistsHormones

Outcome Measures

Primary Outcomes (1)

  • Muscle Strength

    Pre-drug and post-drug 1 RM (Repetition Maximum) testing

    12 weeks

Secondary Outcomes (5)

  • Glucose Homeostasis

    12 weeks

  • Fat-free and Lean Mass

    baseline and 12 weeks

  • Fuel Utilization

    baseline and 12 weeks

  • Physical Performance

    Baseline and 12 weeks

  • Tolerability of Nocturnal Administration

    Ongoing throughout 12 weeks

Study Arms (1)

Growth Hormone Releasing Hormone (GHRH)

EXPERIMENTAL

Drug: GHRH

Drug: Growth Hormone Releasing Hormone (GHRH )

Interventions

Growth Hormone Releasing Hormone (GHRH )DRUG

GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks

Also known as: Growth Hormone Releasing Factor
Growth Hormone Releasing Hormone (GHRH)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age of 65 years or older
  • Fasting IGF-1 level \<135ng/ml
  • BMI 23-40 kg/m2
  • Capable of giving informed consent

You may not qualify if:

  • Diabetes mellitus or use of hypoglycemic agents
  • Known coronary artery disease
  • Liver disease, abnormal liver function tests (LRTs\>2x upper limit of normal) or inflammatory bowel disease
  • Renal insufficiency (serum creatinine \> or = to 1.4 mg/dL)
  • Hematocrit \< 33% or \> 50%
  • History of malignancy \< 5 years other than basal cell of the skin
  • Chronic pulmonary disease or other systemic disorders which affect glucose hemostasis
  • Use of growth hormone, corticosteroids, thiazide diuretics, estrogen supplements or androgen supplements
  • Inability to perform strength or performance testing
  • Uncontrolled hypertension (blood pressure \>160/95
  • NYHA Class III or IV heart failure
  • Current smoking
  • Alcohol use \> or = to 30g/day
  • Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
  • Participation in an investigational drug study within 6 weeks prior to screening visit
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania-UPHS Presbyterian Campus

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone-Releasing Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Results Point of Contact

Title
Dr. Anne Cappola
Organization
University of Pennsylvania
acappola@upenn.edu
215-573-5359

Study Officials

  • Dariush Elahi, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2011

First Posted

August 5, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

May 24, 2019

Results First Posted

May 24, 2019

Record last verified: 2019-05

Locations

US(1)