Status:
COMPLETED
Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT)
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Acromegaly
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Acromegaly is characterized by unrestrained growth hormone (GH) secretion and subsequent elevated insulin-like growth factor (IGF)-1 resulting from a benign somatotroph GH-secreting adenoma in the pit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00915954
Start Date
December 1 2008
End Date
June 1 2014
Last Update
July 9 2019
Active Locations (1)
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1
Cedars-Sinai Medical Center Pituitary Center
Los Angeles, California, United States, 90048