Quitting Caffeine for Better Glucose Metabolism

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Caffeine abstinence

Study type: Interventional

Funder types: NIH

Identifiers

NCT01030796

Pro00011009 (completed)

R01DK067486 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This project is a pilot study of caffeine abstinence in coffee-drinkers who have type 2 diabetes. Evidence suggests that caffeine may impair the control of glucose levels, especially in those people who have type 2 diabetes. Eliminating caffeinated beverages from the diet might improve glucose control, but the difficulty of quitting is unknown. This pilot study will follow a small number of type 2 diabetic patients for three months after a brief intervention designed to help people quit caffeine. Data on success with maintaining abstinence and on changes in glucose control will be collected.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6-month history of type 2 diabetes
• impaired chronic glucose control (HbA1c >= 7%)
• daily consumption of 250 mg caffeine or more in coffee, tea, and other caffeinated beverages

Exclusion criteria

• use of exogenous insulin
• use of non-diabetes medications that impact glucose metabolism
• medical of psychiatric history that prevents participation or increases risk
• current pregnancy
• current participation in other clinical trials
• deemed unable to comply with the study protocol for other reasons

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)