Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT)
Acromegaly, Type 2 Diabetes Mellitus
About this trial
This is an interventional other trial for Acromegaly focused on measuring Acromegaly, Type 2 diabetes mellitus, recombinant human Insulin like growth factor 1 (IGF1), oral glucose tolerance test
Eligibility Criteria
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:
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.
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.
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.
Sites / Locations
- Cedars-Sinai Medical Center Pituitary Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Active Acromegaly
Type 2 Diabetes Mellitus(DM)
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.
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.
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.