Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly

NCT00807365 | Terminated Phase 2 Results DMC

• 3 other identifiers: NA_000057932002P-001781P01-AG0059-21
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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 effectiveness of GHRH to raise levels of GH and improve these body tissues. The purpose of the tests is to measure how the body handles sugar, fat, and proteins. GH can affect your body's use of sugar, fat and proteins.

Conditions

Elderly

Keywords

Growth Hormone-Releasing Hormone; Growth Hormone Insufficiency; Aging; Growth Hormone; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones

Outcome Measures

Primary Outcomes (1)

• Change in Lean Body Mas

  2 years

Study Arms (1)

GHRH

EXPERIMENTAL

Growth Hormone-Releasing Hormone

Drug: GHRH

Interventions

GHRH DRUG

GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 Post Meridian (PM), 1:00 Ante Meridian (AM), 3:00 AM, \& 5:00 AM for 6 months.

Also known as: Growth Hormone-Releasing Hormone

GHRH

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Documentation of low GH levels as assessed by a fasting IGF-1 level \<135ng/ml.
• Volunteers whose BMI is above normal range and below extreme obesity (BMI 25-40 kg/m2).

You may not qualify if:

• Diabetes.
• Known coronary artery disease.
• Liver, peptic or inflammatory bowel disease. Renal or hematologic disease.
• Hematocrit \<30% or \>50%.
• Clinically significant prostate hypertrophy.
• Elevated Prostate specific antigen (PSA) (4ng/ml).
• Prostate \& breast cancer.
• History of malignancy \<5 years other than basal cell of the skin.
• Chronic pulmonary disease or other systemic disorders.
• Use of certain drugs (such as thiazide diuretics, beta-blockers, steroids (except for replacement doses), coumadin, and or androgen supplements).
• Peanut allergy.
• Gross physical impairment.
• Sleep apnea.
• Uncontrolled hypertension(blood pressure \>160/95 and or requiring more than two antihypertensive medications).
• A clinically worrisome mammogram in women.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone-Releasing Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Johns Hopkins ClinicalTrials.gov Program
• Organization: Johns Hopkins University

registerclinicaltrials@jhmi.edu

4105506484

Study Officials

• Dariush Elahi, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Kenneth L. Minaker, MD

  Massachusetts General Hospital

  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: December 10, 2008
• First Posted: December 11, 2008
• Study Start: December 17, 2007
• Primary Completion: April 29, 2010
• Study Completion: April 29, 2010
• Last Updated: April 27, 2017
• Results First Posted: April 27, 2017

Record last verified: 2017-03

Locations

US (2)