NCT Number: NCT00432887
Experimental Studies of the Effects of Caffeine on Glucose Regulation
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Early Phase 1
About this study
Pilot results suggest that caffeine, the most commonly used drug in the world, may interfere with postprandial glucose metabolism by increasing insulin resistance and/or by stimulating hepatic glucose production. This effect could have serious clinical implications for coffee drinkers who have type 2 diabetes. Early results suggest caffeine exaggerates the postprandial hyperglycemia and hyperinsulinemia present in these patients.
The experimental (non-treatment) studies in this project include double-blind placebo-controlled cross-over laboratory tests of glucose tolerance in groups of type 2 diabetic patients and prediabetic volunteers who are coffee drinkers.
The lab studies test the hypothesis that caffeine (vs. placebo) increases postprandial insulin responses and results in a potentiation of glucose responses in the type 2 group.
An ambulatory study examines the effects of caffeine administration on glucose levels during everyday activities in the natural environment. This study uses a double-blind placebo-controlled cross-over design. Ambulatory glucose data are collected with a MiniMed CGMS sensor and recorder worn for 72 hours. Caffeine and placebo are administered on separate days. Average glucose levels and glucose responses to meals are compared across treatment days within subjects.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
postprandial glucose and insulin
-
fasting glucose and insulin
-
insulin resistance
-
glucose tolerance
Secondary outcomes
-
epinephrine
-
norepinephrine
-
cortisol
-
blood pressure
-
plasma caffeine concentration
Sponsors and collaborators
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Nih
Registry information
Official study title
Caffeine and Glucose Regulation
Important dates
- Study start
- 2004
- Study completion
- 2007
- First posted
- Feb 8, 2007
- Registry last updated
- Mar 2, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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