Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

NCTNCT00915954Other id17015

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures IGF-1 (mecasermin), does not give it. It is listed with the interventions, but only as a measurement.

Overview

Status: Completed
Phase: Not applicable
Enrollment: 28 participants (actual)
Sponsor: Cedars-Sinai Medical Center · Other
Design: Not randomized · Single masking
Countries: 1 country
United States
Start: Dec 2008
Primary completion: Aug 2013
Completion: Jun 2014
First posted: 8 Jun 2009 (estimated)
Last update posted: 9 Jul 2019
Conditions: Acromegaly · Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2008201020122014

N/A
Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT)
NCT00915954
Dec 2008 to Jun 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Oral Glucose Tolerance TestDiagnostic test
Subcutaneous administration of recombinant human IGF-1Diagnostic test
PlaceboDiagnostic test

Arms3

Active comparator
Active Acromegaly
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Active comparator
Type 2 Diabetes Mellitus(DM)
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Active comparator
Heathy Controls
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage With Growth Hormone (GH) Suppression to < 0.4 ng/ml
Time frame · Before injection and at time 15, 30, 60, 90, 120 and 180 minutes after rhIGF-1 injection on week 4
Registry description
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.

Secondary outcomes(3)

Median Insulin Like Growth Factor Binding Protein 1 (IGFBP-1) Area Under the Curve in Response to Placebo, Oral Glucose Tolerance Test (OGTT), and rhIGF1 Suppression Testing
Time frame · Before injection at time 0 and then at 15, 30, 60, 90, 120, and 180 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.
Registry description
IGFBP1 levels were measured at time 0 prior to the injection and measured at 15, 30, 60, 90, 120, and 180 minutes after injection. The area under the curve of IGFBP1 was calculated for each subject and the medians calculated for each cohort during the placebo, OGTT, and rhIGF1 tests.
Median Insulin Level in Response to Placebo, OGTT, and rhIGF1 Testing
Time frame · Measured at 120 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.
Registry description
Insulin levels were measured at time 120 minutes after injection. Median insulin was calculated for each cohort during the placebo, OGTT, and rhIGF1 tests.
Median Bioactive IGF-1 Area Under the Curve in Response to Placebo, OGTT, and rhIGF1 Testing
Time frame · Before injection at time 0 and then at 15, 30, 60, 90, 120, and 180 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.
Registry description
Bioactive IGF-1 levels were measured at time 0 prior to the injection and measured at 15, 30, 60, 90, 120, and 180 minutes after injection. The area under the curve of bioactive IGF-1 was calculated for each subject and the medians calculated for each cohort during the placebo, OGTT, and rhIGF1 tests.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Before injection and at time 15, 30, 60, 90, 120 and 180 minutes after rhIGF-1 injection on week 4

Percentage With Growth Hormone (GH) Suppression to < 0.4 ng/ml

Group	Value (Participants)
Active Acromegaly	0
Type 2 Diabetes Mellitus(DM)	7
Heathly Controls	8

Secondary and other outcome results(3)

Secondary outcomeMedian· Before injection at time 0 and then at 15, 30, 60, 90, 120, and 180 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.

Median Insulin Like Growth Factor Binding Protein 1 (IGFBP-1) Area Under the Curve in Response to Placebo, Oral Glucose Tolerance Test (OGTT), and rhIGF1 Suppression Testing

Group	Value (ng*min/mL)
Active Acromegaly	10927
Type 2 Diabetes Mellitus(DM)	5079
Heathly Controls	9105

Secondary outcomeMedian· Measured at 120 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.

Median Insulin Level in Response to Placebo, OGTT, and rhIGF1 Testing

Group	Value (mU/L)
Active Acromegaly	7
Type 2 Diabetes Mellitus(DM)	9
Heathly Controls	4

Secondary outcomeMedian· Before injection at time 0 and then at 15, 30, 60, 90, 120, and 180 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.

Median Bioactive IGF-1 Area Under the Curve in Response to Placebo, OGTT, and rhIGF1 Testing

Group	Value (ng*min/mL)
Active Acromegaly	716
Type 2 Diabetes Mellitus(DM)	291
Heathly Controls	302

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Active AcromegalyPlacebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period. Oral Glucose Tolerance Test: 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-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws. Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.	–	0 / 10	2 / 10
Type 2 Diabetes Mellitus(DM)Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period. Oral Glucose Tolerance Test: 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-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws. Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.	–	0 / 8	0 / 8
Heathly ControlsPlacebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period. Oral Glucose Tolerance Test: 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-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws. Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.	–	0 / 10	0 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Active acromegaly due to excess GH produced by a pituitary adenoma. * Patients must have an elevated IGF-I compared to age and gender matched controls (as supplied by the laboratory) and fail to suppress GH to below 1 ng/ml after a standard 75g oral glucose tolerance test. * Type 2 diabetes mellitus, defined by elevated fasting glucose ≥ 126 mg/dl (verified by two historical measurements), or plasma glucose ≥ 200 mg/dl two hours after a 75 g oral glucose load, or a random glucose ≥ 200 mg/dl. Exclusion Criteria: 1. Acromegaly Group * Current medical therapy for acromegaly including dopamine agonists, somatostatin analogues, or growth hormone antagonists. * For subjects on current therapy the following washout periods may be used: * Cabergoline: 4 weeks * Bromocriptine: 1 week * Sandostatin LAR: 3 months * Short-acting octreotide: 1 week * Lanreotide: 3 months * Pegvisomant: 4 weeks * Subjects with a history of surgical therapy for treatment of acromegaly must have verification of active disease with verified elevated IGF-I for the subjects' age and gender compared to healthy controls (as supplied by the laboratory) (two measures) as well as a failure to suppress GH to below 1 ng/ml after OGTT. * Current treatment for insulin resistance or type 2 DM including oral or injection medications. * Fasting glucose ≥ 126 mg/dl at screening evaluation. * Evidence of hepatic or renal disease defined as elevated transaminases, elevated serum creatinine. * Pregnancy or breast feeding. 2. Type 2 diabetes mellitus group * Patients taking non-insulin medications for diabetes treatment will be excluded. * Diagnosis of acromegaly. * Evidence of hepatic or renal disease defined as elevated transaminases, elevated serum creatinine. * Pregnancy or breast feeding. 3. Healthy Control Group * History of diabetes mellitus or impaired glucose tolerance, history of acromegaly. * Fasting glucose ≥ 126 mg/dl at screening evaluation. * Evidence of hepatic or renal disease defined as elevated transaminases, elevated serum creatinine. * Pregnancy or breast feeding.

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