Experimental Studies of the Effects of Caffeine on Glucose Regulation
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
caffeine administration
Sponsored by

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring caffeine, coffee, glucose, insulin
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
postprandial glucose and insulin
fasting glucose and insulin
insulin resistance
glucose tolerance
Secondary Outcome Measures
epinephrine
norepinephrine
cortisol
blood pressure
plasma caffeine concentration
Full Information
NCT ID
NCT00432887
First Posted
February 5, 2007
Last Updated
March 1, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00432887
Brief Title
Experimental Studies of the Effects of Caffeine on Glucose Regulation
Official Title
Caffeine and Glucose Regulation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
caffeine, coffee, glucose, insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
caffeine administration
Primary Outcome Measure Information:
Title
postprandial glucose and insulin
Title
fasting glucose and insulin
Title
insulin resistance
Title
glucose tolerance
Secondary Outcome Measure Information:
Title
epinephrine
Title
norepinephrine
Title
cortisol
Title
blood pressure
Title
plasma caffeine concentration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D. Lane, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Experimental Studies of the Effects of Caffeine on Glucose Regulation
We'll reach out to this number within 24 hrs