Chapter 5-03: Key Clinical Trials and Publications in Endocrinology

THYROID DISEASE

• Guidelines for the treatment of hypothyroidism: Prepared by the American Thyroid Association task force on thyroid hormone replacement. Thyroid 2014;24(12):1670–1751.

  • - Guidelines about hypothyroidism management.

• 2016 American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis. Thyroid 2016;26(10):1343–1421.

  • - Guidelines about hyperthyroidism and other thyrotoxicosis management.

DIABETES

• Diabetes Control and Complication Trial (DCCT). N Engl J Med 1993;329(14):977–986. Follow-up: N Engl J Med 2000;342(6):381–389.

  • - Multicenter randomized controlled trial that randomized 1441 patients with type 1 diabetes to intensive vs. conventional glycemic control therapy. Patients who kept their blood glucose levels as close to normal as safely possible with intensive diabetes treatment as early as possible in their disease had fewer diabetes-related health problems after 6.5 yr (including diabetic retinopathy, development of kidney and cardiovascular disease), compared to patients who used conventional treatment. Long-term follow-up of these patients demonstrated that these benefits persisted. After 30 yr of follow-up, the group that had tightly controlled blood glucoses in the study had a 32% reduction in major cardiovascular events, suggesting that better control early in DM1 can prevent cardiovascular disease.

• UK Prospective Diabetes Study (UKPDS). Lancet 1998;352:837–853. Follow up: Holman et al. N Engl J Med 2008;359(15):1577–1589.

  • - Multicenter randomized controlled trial that randomized 3867 patients with newly diagnosed DM2 to intensive vs. lenient glycemic control therapy. A follow-up study 10 yr later found that the intensive glucose control group had a lower risk of MIs and death from any cause. Patients who underwent intensive glycemic control (fasting glucose <108 mg/dL) had a 25% reduction in microvascular complications, but there was no effect on macrovascular disease or mortality between treatment groups.

• Nice-Sugar Study. N Engl J Med 2009;360(13):1283–1297.

  • - Multicenter, nonblinded, randomized controlled trial that randomized 6104 patients with diabetes who had been admitted to an intensive care unit and were expected to stay at least 3 days to intensive glucose control (goal glucose 80–108 mg/dL) vs. liberal glucose control (<180 mg/dL). Intensive glucose control led to more deaths than the conventional approach, suggesting more permissive glucose control with glucose <180 mg/dL is preferred in the ICU setting.

DIABETES PREVENTION

• Diabetes Prevention Program (DPP). N Engl J Med 2002;346(6):393–403.

  • - Multicenter, double-blind, randomized controlled trial that randomized 3234 middle-aged adults to intensive lifestyle counseling (dietary changes and 150 minutes of exercise per week for a weight loss goal of ≥7%) versus usual care. The intensive lifestyle counseling reduced the onset of diabetes by 58% compared to usual care. Metformin treatment reduced the onset of diabetes by 31%. These benefits persisted though the study’s 15-yr follow-up.