Type 2 DiabetesNCT00950898
The Acute Effects of Coffee on Glucose Metabolism
A study testing decaff, caffcoff and caffeine in people with Type 2 Diabetes, run by Brooklyn College of the City University of New York at 1 site in United States.
Trial summary
The purpose of this study was to determine the acute effects of decaffeinated coffee, caffeinated coffee and caffeine on glucose metabolism in humans Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- decaff, caffcoff and caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy young males
- nonsmokers
- moderate alcohol users
Who cannot join
- not on any medications that could alter glucose metabolism
- no history of blood disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooklyn College of the City University of New York
Brooklyn, New York, 11210
About this study
Official title: Human Trial of the Acute Effects of Coffee on Glucose Metabolism
The purpose of this study was to determine the acute effects of decaffeinated coffee, caffeinated coffee and caffeine on glucose metabolism in humans
- Conditions
- Type 2 Diabetes
- Being tested
- decaff, caffcoff, caffeine, placebo
- Keywords
- coffee, caffeine, glucose metabolism, insulin sensitivity, diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decaffOther
2 mugs of decaffeinated coffee
caffcoffOther
2 mugs of caffeinated coffee
caffeineOther
2 mugs of hot water containing caffeine
placeboOther
2 mugs of hot water
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma glucose levels
Measured: 0, 10, 30, 60, 90, and 120 minutes.
Secondary outcomes (1)
plasma insulin
Measured: 0, 10, 30, 60, 90, and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startNov 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooklyn College of the City University of New York
- Sponsor type
- University, hospital or other
- Investigators
- James Greenberg, Ph.D., Principal investigator, Brooklyn College of the City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950898
- Sponsor's protocol ID
- 07-020
- Status last verified
- Jul 2009
- First submitted
- 31 Jul 2009
- Last updated
- 3 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Trial of the Acute Effects of Coffee on Glucose Metabolism
- ClinicalTrials.gov ID
- NCT00950898
- Acronym / sponsor ID
- 07-020
- Conditions
- Type 2 Diabetes
- Keywords
- coffee, caffeine, glucose metabolism, insulin sensitivity, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brooklyn College of the City University of New YorkUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 3 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the acute effects of decaffeinated coffee, caffeinated coffee and caffeine on glucose metabolism in humans
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy young males
- nonsmokers
- moderate alcohol users
Key exclusion criteria (2 listed)
- not on any medications that could alter glucose metabolism
- no history of blood disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decaff2 mugs of decaffeinated coffee | Other | – |
| caffcoff2 mugs of caffeinated coffee | Other | – |
| caffeine2 mugs of hot water containing caffeine | Other | – |
| placebo2 mugs of hot water | Other | – |
Primary outcome
plasma glucose levels
Time frame: 0, 10, 30, 60, 90, and 120 minutes.
1 secondary outcome
plasma insulin
Time frame: 0, 10, 30, 60, 90, and 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Greenberg, Ph.D. principal investigator
Brooklyn College of the City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decaff, caffcoff and caffeine in people with Type 2 Diabetes, run by Brooklyn College of the City University of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma glucose levels (time frame: 0, 10, 30, 60, 90, and 120 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2009.