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NCT00915954 · ClinicalTrials.gov registry record · NA

Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT)

A NA study, sponsored by Cedars-Sinai Medical Center.

Completed
Registry status
NA
Development phase
28
Enrollment target

NCT00915954 is a NA study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 28 participants.

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The verdict

NCT00915954, a NA study, has completed, sponsored by Cedars-Sinai Medical Center.

COMPLETED
Registry status
NA
Development phase
28 participants
Enrollment target

Study Summary

Growth hormone (GH) and Insulin-like growth factor-I (IGF-I) secretion are altered in acromegaly and type 2 Diabetes Mellitis (DM). The secretion of GH is mediated by central hypothalamic hormones (GH Releasing Hormone and somatostatin) as well as peripheral factors providing feedback inhibition (IGF-I and glucose, among others). The purpose of this study is to compare growth hormone suppression after an oral glucose tolerance test (OGTT) to growth hormone suppression after recombinant human IGF-I (rhIGF-I) administration. This study will recruit participants with active acromegaly, type 2 diabetes mellitus, and healthy control subjects. Each participant will undergo a screening evaluation, and three subsequent visits. Each participant will receive a placebo subcutaneous injection, OGTT, and administration of rhIGF-I, on separate visit days. Glucose, insulin, GH, bioactive IGF-I and IGF-I binding proteins will be measured after each intervention. Results will be compared between the three groups. It is predicted that the administration of rhIGF-I will demonstrate GH suppression in all healthy subjects and subjects with type 2DM. Some acromegaly subjects may demonstrate GH suppression in response to IGF-I administration, but not to the degree seen in healthy subjects or type 2 DM. OGTT will demonstrate suppression of GH in normal subjects, and will show attenuated suppression in type 2 DM and a failure of suppression in acromegaly.

Interventions

  • DIAGNOSTIC_TEST Oral Glucose Tolerance Test
  • DIAGNOSTIC_TEST Subcutaneous administration of recombinant human IGF-1
  • DIAGNOSTIC_TEST Placebo

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2008-12
Est. Completion 2014-06
Phase NA

Sponsor

Cedars-Sinai Medical Center

339 total trials

What the Registry Record Tells You About NCT00915954

The ClinicalTrials.gov registry entry for NCT00915954 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Oral Glucose Tolerance Test is the first listed.

NCT00915954 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00915954 about?

NCT00915954 is a clinical study titled "Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT)". Growth hormone (GH) and Insulin-like growth factor-I (IGF-I) secretion are altered in acromegaly and type 2 Diabetes Mellitis (DM). The secretion of GH is mediated by central hypothalamic hormones (GH Releasing Hormone and somatostatin) as well as peripheral factors providing feedback inhibition (IG...

What is the current status of trial NCT00915954?

This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2008-12. Estimated completion is 2014-06.

What interventions are being tested in trial NCT00915954?

The interventions under investigation include: Oral Glucose Tolerance Test (DIAGNOSTIC_TEST), Subcutaneous administration of recombinant human IGF-1 (DIAGNOSTIC_TEST), Placebo (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT00915954?

This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.