NCT01030796

CompletedPhase 1

Quitting Caffeine for Better Glucose Metabolism

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

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Other study identifiers

Sponsor study identifier

Pro00011009 (completed)

Secondary identifiers

R01DK067486

NIH

Study Type

interventional

Estimated enrollment

25

Locations

1 country

Sites

1

Timeline

Study Start

December 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2010

Actual (reported)

Study Completion

April 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 25 participants
Study completion date: April 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2009
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 10, 2009
Actual (reported)
First Posted
December 11, 2009
Actual (reported)
Primary Completion
April 2010
Actual (reported)
Study Completion
April 2010
Actual (reported)

Last Updated: February 7, 2011
Status Verified: February 2011
Last Update Submitted: 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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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%)

Sponsors & Collaborators

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

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

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 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2010

Actual (reported)

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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.

Study Completion

April 2010

Actual (reported)

Last Updated

February 7, 2011

Record last verified: 2011-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT01030796
Data provider: ClinicalTrials.gov
Source updated: 2011-02-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:01 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations