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Quitting Caffeine for Better Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT01030796
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : February 7, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Caffeine abstinence Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quitting Caffeine for Better Glucose Metabolism
Study Start Date : December 2009
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Caffeine abstinence [ Time Frame: baseline, 2 weeks, 1, 2, and 3 months ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: Baseline, 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030796


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: James D Lane, Ph.D. Duke University
More Information

Responsible Party: James D. Lane, Ph.D., Professor, Duke University School of Medicine
ClinicalTrials.gov Identifier: NCT01030796     History of Changes
Other Study ID Numbers: Pro00011009 (completed)
R01DK067486 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: February 7, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents