CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Oral Glucose Tolerance Test +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00915954
NCT00915954N/ACompleted

Growth Hormone Feedback In Patients With Acromegaly, Type 2 Diabetes Mellitus, And Healthy Adults

Cedars-Sinai Medical Center·interventional·Posted Jun 8, 2009·Updated Jul 9, 2019

In Brief

A clinical study evaluating Oral Glucose Tolerance Test, Subcutaneous administration of recombinant human IGF-1, and 1 other intervention for Acromegaly and Type 2 Diabetes Mellitus. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2009
Enrollment StartDec 1, 2008
Primary CompletionAug 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 17.1 years ago

Interventions

Oral Glucose Tolerance Testother

Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.

Subcutaneous administration of recombinant human IGF-1other

Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.

Placeboother

Participants will receive a subcutaneous injection of saline followed by a series of blood draws.