Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance - Full Text View

Purpose

OBJECTIVES: I. Determine the efficacy and toxic effects of recombinant human insulin-like growth factor I (rhIGF-I) on carbohydrate tolerance, insulin action, insulin secretion, hyperandrogenism, and hyperlipidemia in patients with severe insulin resistance who have failed other therapies.

II. Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and secondary abnormalities in this patient population.

III. Determine the effect of rhIGF-I on insulin clearance, the regulation of insulin-like growth factor binding protein 1, the regulation of sex hormone binding globulin, and hypothalamic pituitary gonadal axis in this patient population.

Condition	Intervention
Insulin Resistance Hyperglycemia	Drug: insulin-like growth factor I

Drug Information available for:

Insulin Insulin-like growth factor I Mecasermin rinfabate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	18
Study Start Date:	April 1998

Detailed Description:

PROTOCOL OUTLINE: This is an open label study. Patients receive the first dose of subcutaneous recombinant human insulin-like growth factor I (rhIGF-I) on day 7.

Patients receive rhIGF-I twice daily 15-30 minutes before breakfast and dinner, and are hospitalized for the first week of therapy. Patients return for an outpatient exam on day 19 of rhIGF-I therapy. Approximately 30 days into the therapy, patients are readmitted to the clinical center for repeat screening tests. Patients then receive maintenance therapy of rhIGF-I for up to 6-12 months. A washout period follows the maintenance therapy phase.

Patients are followed weekly, biweekly, or monthly depending on blood glucose response of patients off rhIGF-I therapy. Weekly phone contact with study coordinator is mandatory during this time.

Eligibility

Ages Eligible for Study:	14 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Hematologically proven severe insulin resistance with or without diabetes
Fasting insulin greater than 40 U/mL
Post glucose insulin greater than 300 U/mL (unless overt diabetes mellitus is present)

--Prior/Concurrent Therapy--

Endocrine therapy: No concurrent oral hypoglycemic agents and/or insulin

Other: No concurrent birth control pills

--Patient Characteristics--

Not pregnant
Negative pregnancy test
Effective barrier contraceptive method must be used by fertile patients
Good health

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004419

Locations


United States, Massachusetts
	Beth Israel Deaconess Medical Center	Recruiting
	Boston, Massachusetts, United States, 02215
	Contact: Alan C. Moses 617-667-4269

Sponsors and Collaborators

FDA Office of Orphan Products Development

Beth Israel Deaconess Medical Center

Investigators


Study Chair:	Alan C. Moses	Beth Israel Deaconess Medical Center

More Information

Study ID Numbers:	199/13313, BIH-98-1060, BIH-E-147, BIH-FDR001126
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004419
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

endocrine disorders

insulin resistance

rare disease

Study placed in the following topic categories:

Hyperinsulinism

Metabolic Diseases

Hyperglycemia

Rare Diseases

Endocrine System Diseases

Endocrinopathy

Insulin Resistance

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsors and Collaborators:	FDA Office of Orphan Products Development Beth Israel Deaconess Medical Center
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004419