| Exclusion Criteria for ACCORD | |
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Exclusion criteria were selected
to enhance safety and adherence. 1.
History of hypoglycemic coma/seizure within last 12 months 2.
Hypoglycemia requiring 3
rd
party assistance in last 3 months with concomitant
glucose <60 mg/dl
3.
History consistent with type 1 diabetes 4.
Unwilling to do frequent capillary blood glucose self-monitoring or unwilling
to inject insulin several times a day 5. Body
mass index >45 kg/m2 6. Serum
creatinine >1.5 mg/dl
7. Transaminase
>2 times upper limit of normal or active liver disease 8. Any
ongoing medical therapy with known adverse interactions with the glycemic
interventions (e.g., corticosteroids, protease inhibitors) 9.
Cardiovascular event or procedure (as defined for study entry) or
hospitalization for unstable angina within last 3 months 10.
Current symptomatic heart failure, history of NYHA Class III or IV congestive
heart failure at any time, or ejection fraction (by any method) <25%
11. A medical condition likely to limit survival to less than 3 years or a malignancy
other than non-melanoma skin cancer within the last 2 years
12. Any factors likely to limit adherence to interventions. For example,
• dementia
•
alcohol or substance abuse • plans
to move in the next 2 years.
• history of unreliability in medication taking or appointment keeping
• significant concerns about participation in the study from spouse, significant
other, or family members
• lack of support from primary health care provider
13. Currently participating in another clinical trial.
14. Living in the same household as an already randomized ACCORD participant.
15. Any organ transplant
16. Weight loss >10% in last 6 months
17. Pregnancy, currently trying to become pregnant, or of child-bearing potential
and not practicing birth control
18. Participants with recurrent requirements for phlebotomy or transfusion of red blood cells.
The additional exclusion criteria for the lipid intervention are:
• known hypersensitivity to statins or fibrates
• requirements for use of erythromycin, clarithromycin,
cyclosporine, systemic azole antifungals, or nefazodone or trazodone
• unwilling to stop current lipid-lowering drugs .
•
history of pancreatitis •
untreated or inadequately treated thyroid disease
• women
who are breast feeding •
documented previous occurrence of myositis/myopathy •
pre-existing gallbladder disease (eg., history of gallstones) |