Quitting Caffeine for Better Glucose Metabolism

NCT ID: NCT01030796

Last Updated: 2011-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Caffeine abstinence

Brief instruction on beginning and maintaining caffeine abstinence.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role lead

Responsible Party

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Duke University School of Medicine

Principal Investigators

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James D Lane, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK067486

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00011009 (completed)

Identifier Type: -

Identifier Source: org_study_id

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