[c09aa8]: / clusters / intermediateclusters / clust_131.txt

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Patient with poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL; optimally participants will have glucose < 150 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medicationsXx_NEWLINE_xXRandom or fasting blood glucose within the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then a follow-up fasting blood glucose can be obtained and must be within the upper normal limits for ageXx_NEWLINE_xXDiabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dLXx_NEWLINE_xXTREATMENT: Patients who have poorly controlled diabetes (defined as fasting blood glucose of > 160 mg/dL (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) and glycated hemoglobin (HgA1c) > 8% are ineligible to receive treatment with everolimus on study; patients with fasting blood glucose > 160 mg/dL may be eligible if the HgA1c < 8%, per PI discretionXx_NEWLINE_xXIt is recommended glucose be drawn fasting >= 8 hrs; glucose < 126 (diabetics 40�75 years of age are not eligible), within 30 days prior to enrollment* If glucose is >= 126 the glucose should be repeated fasting to determine eligibilityXx_NEWLINE_xXFasting serum glucose =< 130 MG/DLXx_NEWLINE_xXFasting serum glucose =< 130 mg/dLXx_NEWLINE_xXUncontrolled diabetes (fasting serum glucose > 130 mg/dl) despite best medical management or poorly controlled diabetes mellitus defined as hemoglobin (Hb)A1c > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXPatients must have a normal blood sugar level for age to participate; if an initial random draw (ie. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting drawXx_NEWLINE_xXFasting serum glucose =< 130 mg/dLXx_NEWLINE_xXFasting serum glucose =< 130 mg/dLXx_NEWLINE_xXUncontrolled diabetes mellitus (fasting plasma glucose > 130 mg/dL)Xx_NEWLINE_xXPatient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL)Xx_NEWLINE_xXFasting blood glucose (FBG) < 130 mg/dLXx_NEWLINE_xXFasting plasma glucose =< 130 mg/dL (or 7.2 mmol/L)Xx_NEWLINE_xXPatients with uncontrolled diabetes mellitus (fasting blood glucose controlled by medication, =< 200 mg/dL allowed)Xx_NEWLINE_xXNormal blood glucose for ageXx_NEWLINE_xXWithin less than or equal to 14 days prior to registration: Fasting serum glucose =< 130 mg/dLXx_NEWLINE_xXDiabetics are allowed if:* Fasting blood glucose (FBG) =< 130 mg/dL (mmol/L),OR* HbA1c =< 7%Xx_NEWLINE_xXRandom or fasting blood glucose =< the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then follow-up fasting blood glucose can be obtained and must be =< the upper normal limits for ageXx_NEWLINE_xXPatients must have a normal blood sugar level for age; if an initial random draw (i.e. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting drawXx_NEWLINE_xX