Experimental Studies of the Effects of Caffeine on Glucose Regulation
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: caffeine administration (Drug)
Phase: Phase 0
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Official(s) and/or principal investigator(s): James D. Lane, Ph.D., Principal Investigator, Affiliation: Duke University
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.
Clinical Details
Official title: Caffeine and Glucose Regulation
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: postprandial glucose and insulinfasting glucose and insulin insulin resistance glucose tolerance
Secondary outcome: epinephrinenorepinephrine cortisol blood pressure plasma caffeine concentration
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: July 2004
Last updated: March 1, 2010
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