Experimental Studies of the Effects of Caffeine on Glucose Regulation

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This project contains experimental studies of the effects of the drug caffeine on glucose regulation in adults who have Type 2 diabetes. In our experiments, we are testing the hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and insulin observed after meals in patients with type 2 diabetes. On separate study days subjects receive standard meals after taking capsules containing either caffeine or an inactive placebo. We measure levels of glucose, insulin, and other chemicals in blood samples drawn over the next 3 hours. In a separate study, we use continuous glucose monitoring to measure glucose levels during everyday activities on days when subjects receive caffeine or placebo.

These studies do not involve clinical treatment or disease management. However, we hope to learn whether a very popular drug impairs the clinical management of a common disease.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Caffeine

Criteria

Inclusion criteria:

• 6 months or longer history of type 2 diabetes

• treatment by diet, exercise, or oral medication

• current daily consumption of 2 or more cups of coffee

• BMI >21kg/M2 and < 45kg/M2

Exclusion criteria:

• Required use of insulin

• Current cigarette smoking

• Current use of medications that impact glucose metabolism

• Pregnancy

• Other major medical disorders