Quitting Caffeine for Better Glucose Metabolism

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Quitting Caffeine for Better Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030796
• Other study ID #: Pro00011009 (completed)
• Secondary ID: R01DK067486
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2009
• Last updated: February 3, 2011
• Start date: December 2009
• Est. completion date: April 2010

Study information

• Verified date: February 2011
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Caffeine abstinence
Brief instruction on beginning and maintaining caffeine abstinence.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caffeine abstinence		baseline, 2 weeks, 1, 2, and 3 months	No
Secondary	HbA1c		Baseline, 3 months	No