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
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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 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 May 22, 2013