NCT01030796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 7, 2011

Status Verified

February 1, 2011

Enrollment Period

4 months

First QC Date

December 10, 2009

Last Update Submit

February 3, 2011

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Caffeine abstinence

    baseline, 2 weeks, 1, 2, and 3 months

Secondary Outcomes (1)

  • HbA1c

    Baseline, 3 months

Interventions

Caffeine abstinenceBEHAVIORAL

Brief instruction on beginning and maintaining caffeine abstinence.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • James D Lane, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

December 10, 2009

First Posted

December 11, 2009

Study Start

December 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 7, 2011

Record last verified: 2011-02

Locations

US(1)