Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
BEHAVIORALCaffeine abstinence
Brief instruction on beginning and maintaining caffeine abstinence.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Caffeine abstinence | baseline, 2 weeks, 1, 2, and 3 months |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | Baseline, 3 months |
Countries
United States
Outcome results
None listed