Experimental Studies of the Effects of Caffeine on Glucose Regulation

NCT00432887 | Completed Early Phase 1

• 1 other identifier: DK67486 (completed)
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

caffeine; coffee; glucose; insulin

Outcome Measures

Primary Outcomes (4)

• postprandial glucose and insulin

• fasting glucose and insulin

• insulin resistance

• glucose tolerance

Secondary Outcomes (5)

• epinephrine

• norepinephrine

• cortisol

• blood pressure

• plasma caffeine concentration

Interventions

caffeine administration DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Required use of insulin
• Current cigarette smoking
• Current use of medications that impact glucose metabolism
• Pregnancy
• Other major medical disorders

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• James D. Lane, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 5, 2007
• First Posted: February 8, 2007
• Study Start: July 1, 2004
• Study Completion: February 1, 2007
• Last Updated: March 2, 2010

Record last verified: 2010-03