Type 2 Diabetes Mellitus Clinical Trial
Official title:
Growth Hormone Feedback In Patients With Acromegaly, Type 2 Diabetes Mellitus, And Healthy Adults
NCT number | NCT00915954 |
Other study ID # | 17015 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2008 |
Est. completion date | June 2014 |
Verified date | July 2019 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | June 2014 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center Pituitary Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage With Growth Hormone (GH) Suppression to < 0.4 ng/ml | 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 | Before injection and at time 15, 30, 60, 90, 120 and 180 minutes after rhIGF-1 injection on week 4 | |
Secondary | 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 | 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. | 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. | |
Secondary | Median Insulin Level in Response to Placebo, OGTT, and rhIGF1 Testing | Insulin levels were measured at time 120 minutes after injection. Median insulin was calculated for each cohort during the placebo, OGTT, and rhIGF1 tests. | Measured at 120 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively. | |
Secondary | Median Bioactive IGF-1 Area Under the Curve in Response to Placebo, OGTT, and rhIGF1 Testing | 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. | 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. |
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