Top Document: diabetes FAQ: research (part 5 of 5) Previous Document: What is the DCCT? What are the results? Next Document: DCCT philosophy: what did it really show? See reader questions & answers on this topic! - Help others by sharing your knowledge The study placed subjects into two cohorts, primary prevention or secondary intervention, depending on duration of diabetes and existing complications -- the primary prevention cohort were those with essentially no complications. Specifically: all subjects met these criteria: Insulin dependent as evidenced by deficient C-peptide secretion Age 13 to 39 years at entry to the study No hypertension, hypercholesterolemia, severe diabetic complications, or other severe medical conditions Meet the criteria for one of the cohorts and were separated into the two cohorts by these criteria: Primary Secondary Prevention Intervention Cohort Cohort Duration of IDDM 1-5 yrs 1-15 yrs Retinopathy none detectable very mild to moderate nonproliferative Urinary albumin < 40 mg / 24 hr < 200 mg / 24 hr Within each cohort, the subjects were randomly assigned to either conventional therapy or intensive therapy. Thus the study compared intensive to conventional therapy in two different cohorts. The two questions the study was mainly designed to answer were 1) Will intensive therapy prevent the development of diabetic retinopathy in patients with no retinopathy (primary prevention), and 2) Will intensive therapy affect the progression of early retinopathy (secondary intervention)? Conventional therapy included one or two injections per day, daily self monitoring of blood or urine glucose, education, quarterly consultations, and intensive therapy during pregnancy. Intensive therapy included three or more daily injections or an insulin pump, bG monitoring at least 4x/day, adjustment of insulin dosage for bG level and food and exercise, monthly personal consultations and more frequent phone consultations. To simplify a lot, the DCCT showed the following changes in the intensive therapy groups compared to the conventional therapy groups. Note that '-' shows a decrease, '+' shows an increase, in the number of patients affected. Patients were judged as affected or not based on binary criteria, so the results only say how many subjects were affected, not how severely those subjects were affected. Intensive therapy compared to conventional therapy: Primary Secondary Complication Prevention Combined Intervention ------------ ---------- -------- ------------ Retinopathy(*) - 75% - 55% Nephropathy(*) - 35% - 45% Neuropathy(*) - 70% - 55% Hypoglycemia(*) +200% Weight gain(*) + 33% Hypercholesterolemia(*) - 35% (*) This brief table begs many questions about what exactly was measured and how. For more details, read the paper. There were no detectable differences on several measures: Macrovascular disease Mortality Changes in neuropsychological function (a feared result of severe hypoglycemia) Quality of life (based on a questionnaire) Some limitations of the study: type 1 only, patients young and with short duration (under 15 years) of diabetes, and short duration of the study (5-9 years). Measured only number of subjects affected according to binary criteria, not by measurement of severity of complications. Excluded patients who already had severe complications and who thus might benefit the most. The difference between the groups increased during the study, but there is no proof that the difference would continue to increase with time. It is tempting to extrapolate the results to all diabetic patients -- all types, ages, and durations -- and there is at least some support for doing so. However, the DCCT by itself does not show results for type 2 patients, older patients, patients who have had diabetes for many years, or those who already have severe complications. On the other hand, a different group of subjects might shows differences in areas such as mortality and macrovascular disease, where the young DCCT cohorts simply did not have significantly measurable incidence. The DCCT subjects are being tracked in a followup study which may shed light on some of the unanswered questions. Secondary analysis of the data indicates that retinopathy decreases with decreasing HbA1c. This measure was not part of the study design and is more difficult to interpret, but still shows clearly a correlation between HbA1c and retinopathy. User Contributions:Comment about this article, ask questions, or add new information about this topic:Top Document: diabetes FAQ: research (part 5 of 5) Previous Document: What is the DCCT? What are the results? Next Document: DCCT philosophy: what did it really show? Part1 - Part2 - Part3 - Part4 - Part5 - Single Page [ Usenet FAQs | Web FAQs | Documents | RFC Index ] Send corrections/additions to the FAQ Maintainer: edward@paleo.org
Last Update March 27 2014 @ 02:11 PM
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