NCT00004419

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 1998

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2000

Completed
Last Updated

March 25, 2015

Status Verified

June 1, 1999

First QC Date

October 18, 1999

Last Update Submit

March 24, 2015

Conditions

Insulin ResistanceHyperglycemia

Keywords

endocrine disordersinsulin resistancerare disease

Interventions

insulin-like growth factor IDRUG

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Insulin ResistanceHyperglycemiaEndocrine System DiseasesRare Diseases

Interventions

Insulin-Like Growth Factor I

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SomatomedinsInsulin-Like PeptidesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsBlood ProteinsProteinsBiological Factors

Study Officials

  • Alan C. Moses

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

April 1, 1998

Study Completion

September 1, 2000

Last Updated

March 25, 2015

Record last verified: 1999-06

Locations

US(1)