Quitting Caffeine for Better Glucose Metabolism

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine abstinence

Behavioral

Brief instruction on beginning and maintaining caffeine abstinence.

Primary outcomes

Caffeine abstinence

Time frame: baseline, 2 weeks, 1, 2, and 3 months

Secondary outcomes

HbA1c

Time frame: Baseline, 3 months

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 11, 2009
Registry last updated: Feb 7, 2011

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.

Published trials that share one or more normalized conditions with this study.

Completed