Download - DCCT Landmark Trial
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Grethel Fatima Castañeda, MD With
Hannah Urbanozo-Corpuz, MD, FPCP, FPSEDM
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9 February 2017
Journal Club
GRETHEL FATIMA CASTAÑEDA, MD WITH
HANNAH URBANOZO-CORPUZ, MD, FPCP, FPSEDM
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What is the DCCT?
◦ Diabetes Control and Complications Trial (DCCT)
◦ major clinical study conducted from 1983 to 1993
◦ National Institute of Diabetes and Digestive and Kidney Diseases
◦ The study compared the effects of standard control of blood glucose versus
intensive control on the complications of diabetes.
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Diabetes Control and Complications Trial
Conventional Treatment
◦ 1-2 insulin injections per day
Intensive Treatment
◦ > 3 insulin injections per day
◦ Insulin pump
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DCCT (1983-1993) ◦ Study Design: parallel-arm, randomized clinical trial
◦ Study Population: 1441 IDDM, 13-39yrs old ◦ primary prevention cohort (726 no retinopathy)
◦ secondary intervention cohort (715 mild retinopathy)
◦ Intervention: (unmasked)
◦ Intensive arm: insulin pump or ≥ 3 daily insulin injections
◦ Conventional arm: 1-2 insulin injections
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ELIGIBILITY CRITERIA PRIMARY PREVENTION SECONDARY PREVENTION
MAJOR CRITERIA Insulin dependence
13-39 y/o
No hypertension, hypercholesterolemia or severe diabetic complications
IDDM for 1-5 years IDDM for 1-15 years
No retinopathy Mild to moderate retinopathy
Urine albumin <40mg in 24 hrs Urine albumin <200mg in 24 hrs
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CLINICAL QUESTIONS
Primary prevention
◦ Will an intensive treatment program prevent the development of retinopathy in patients with no retinopathy?
Secondary intervention
◦ Will such an intervention affect the progression of early retinopathy to more advanced forms of retinopathy?
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RESULTS
◦ 99% competed the study
◦ 11 died
◦ 32 inactive
◦ 8 lost to ff up
◦ 95 women, originally on conventional treatment transferred
to intensive treatment during pregnancy
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How did intensive treatment affect diabetic eye disease? ◦ All DCCT participants were monitored for diabetic retinopathy
◦ Study results showed that intensive therapy reduced the risk for
developing retinopathy by 76 percent.
◦ In participants who had some eye damage at the beginning of
the study, intensive management slowed the progression of the
disease by 54 percent.
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How did intensive treatment affect diabetic kidney disease? ◦ Participants in the DCCT were tested to assess the development of diabetic kidney disease, or nephropathy.
◦ Findings showed that intensive treatment prevented the development and slowed the progression of diabetic kidney disease by 56 percent.
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How did intensive treatment affect diabetic nerve disease?
◦ Participants in the DCCT were examined to detect the development of nerve damage, or diabetic neuropathy.
◦ Study results showed the risk of nerve damage was reduced by 60 percent in people on intensive treatment.
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intensive
conventional
Abnormal
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How did intensive treatment affect diabetes-related cardiovascular disease?
◦ Detection macrovascular events were unlikely due to short time frame.
◦ Reduced development of hypercholesterolemia (LDL >160mg/dl) by 34%
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What are the risks of intensive treatment? ◦ HYPOGLYCEMIA ◦ 3x increase both in the intensive and conventional treatment groups ◦ 62 px in intensive vs 19 px in conventional treatment ◦ Seizure due to hypoglycemia - 16 px in intensive vs 5 px in conventional treatment ◦ 2 – vehicular accident ◦ Hospitalization due to hypoglycemia - 54 px in intensive vs 36 px in conventional treatment
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What are the risks of intensive treatment? ◦ WEIGHT GAIN ◦ Body weight > 120% of IBW ◦ Increased by 33% in intensive treatment
◦ DKA ◦ 1.8 episodes in conventional treatment ◦ 2 episodes in intensive treatment
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SUMMARY and RECOMMENDATIONS
◦ Intensive therapy delays the progression of clinically important retinopathy.
◦ There is transient worsening of retinopathy with intensive therapy which
occurred mainly on the first year of therapy.
◦ Intensive therapy reduced the risk of albuminuria and microalbuminuria.
◦ Whether the decrease in albuminuria and microalbuminuria result in the
decrease of renal insufficiency, follow-up of the entire cohort must be
done.
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SUMMARY and RECOMMENDATIONS
◦ The ability of intensive therapy to reduce development of neuropathy
suggests that neuropathy may be preventable.
◦ Whether intensive therapy may reduce macrovascular complications
requires further investigation.
◦ Benefits of reducing hyperglycemia are extended to NIDDM patients
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• IDDM patient are better treated with closely monitored intensive therapy.
• Keeping blood glucose levels as close to normal as possible slows the onset and progression of the eye, kidney, and nerve damage caused by diabetes.
• The study demonstrated that any sustained lowering of blood glucose helps, even if the person has a history of poor control.
LEARNING POINTS