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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: Completed NA study, sponsored by Cedars-Sinai Medical Center.

NCT00915954 is a NA study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Subjects underwent recombinant insulin like growth factor 1 (rhIGF1) suppression testing and growth hormone levels were measured at time 0, 15, 30, 60, 90, 120, and 180 minutes after injection of rhIGF-1. A response \</= 0.4 ng/ml is considered a normal response in the healthy control and diabetic control subjects. The percentage of subjects with a normal GH suppression to \</= 0.4 ng/ml was calculated.

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
Cedars-Sinai Medical Center

339 total trials

What the finished NCT00915954 record still lists

NCT00915954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

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

NCT00915954 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00915954's enrollment target sits among peer trials

28 1704th of 2000 higher than 293 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00915954, the US trial registry maintained by the National Library of Medicine. NCT00915954 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.