Quitting Caffeine for Better Glucose Metabolism

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01030796
First received: December 10, 2009
Last updated: February 3, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Behavioral: Caffeine abstinence
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quitting Caffeine for Better Glucose Metabolism

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Caffeine abstinence [ Time Frame: baseline, 2 weeks, 1, 2, and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: December 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Caffeine abstinence
    Brief instruction on beginning and maintaining caffeine abstinence.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030796

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Investigators
Principal Investigator: James D Lane, Ph.D. Duke University
  More Information

No publications provided

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
Study First Received: December 10, 2009
Last Updated: February 3, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 28, 2014