Diabetes Mellitus, Type 2Early Phase 1NCT00432887
Experimental Studies of the Effects of Caffeine on Glucose Regulation
A Early Phase 1 study testing caffeine administration in people with Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial summary
This project contains experimental studies of the effects of the drug caffeine on glucose regulation in adults who have Type 2 diabetes. In our experiments, we are testing the hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and insulin observed after meals in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- caffeine administration
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Feb 2007
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6 months or longer history of type 2 diabetes
- treatment by diet, exercise, or oral medication
- current daily consumption of 2 or more cups of coffee
- BMI >21kg/M2 and < 45kg/M2
Who cannot join
- Required use of insulin
- Current cigarette smoking
- Current use of medications that impact glucose metabolism
- Pregnancy
- Other major medical disorders
About this study
Official title: Caffeine and Glucose Regulation
This project contains experimental studies of the effects of the drug caffeine on glucose regulation in adults who have Type 2 diabetes. In our experiments, we are testing the hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and insulin observed after meals in patients with type 2 diabetes. On separate study days subjects receive standard meals after taking capsules containing either caffeine or an inactive placebo. We measure levels of glucose, insulin, and other chemicals in blood samples drawn over the next 3 hours. In a separate study, we use continuous glucose monitoring to measure glucose levels during everyday activities on days when subjects receive caffeine or placebo.
These studies do not involve clinical treatment or disease management. However, we hope to learn whether a very popular drug impairs the clinical management of a common disease.
Read the detailed description
Pilot results suggest that caffeine, the most commonly used drug in the world, may interfere with postprandial glucose metabolism by increasing insulin resistance and/or by stimulating hepatic glucose production. This effect could have serious clinical implications for coffee drinkers who have type 2 diabetes. Early results suggest caffeine exaggerates the postprandial hyperglycemia and hyperinsulinemia present in these patients.
The experimental (non-treatment) studies in this project include double-blind placebo-controlled cross-over laboratory tests of glucose tolerance in groups of type 2 diabetic patients and prediabetic volunteers who are coffee drinkers.
The lab studies test the hypothesis that caffeine (vs. placebo) increases postprandial insulin responses and results in a potentiation of glucose responses in the type 2 group.
An ambulatory study examines the effects of caffeine administration on glucose levels during everyday activities in the natural environment. This study uses a double-blind placebo-controlled cross-over design. Ambulatory glucose data are collected with a MiniMed CGMS sensor and recorder worn for 72 hours. Caffeine and placebo are administered on separate days. Average glucose levels and glucose responses to meals are compared across treatment days within subjects.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- caffeine administration
- Keywords
- caffeine, coffee, glucose, insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeine administrationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial glucose and insulin
fasting glucose and insulin
insulin resistance
glucose tolerance
Secondary outcomes (5)
epinephrine
norepinephrine
cortisol
blood pressure
plasma caffeine concentration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startJul 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- James D. Lane, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432887
- Sponsor's protocol ID
- DK67486 (completed)
- Status last verified
- Mar 2010
- First submitted
- 5 Feb 2007
- Last updated
- 2 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine and Glucose Regulation
- ClinicalTrials.gov ID
- NCT00432887
- Acronym / sponsor ID
- DK67486 (completed)
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- caffeine, coffee, glucose, insulin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jul 2004
- Study completion
- Feb 2007
- First posted
- 8 Feb 2007 (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.
This project contains experimental studies of the effects of the drug caffeine on glucose regulation in adults who have Type 2 diabetes. In our experiments, we are testing the hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and insulin observed after meals in patients with type 2 diabetes. On separate study days subjects receive standard meals after taking capsules containing either caffeine or an inactive placebo. We measure levels of glucose, insulin, and other chemicals in blood samples drawn over the next 3 hours. In a separate study, we use continuous glucose monitoring to measure glucose levels during everyday activities on days when subjects receive caffeine or placebo.
These studies do not involve clinical treatment or disease management. However, we hope to learn whether a very popular drug impairs the clinical management of a common disease.
Detailed description
Pilot results suggest that caffeine, the most commonly used drug in the world, may interfere with postprandial glucose metabolism by increasing insulin resistance and/or by stimulating hepatic glucose production. This effect could have serious clinical implications for coffee drinkers who have type 2 diabetes. Early results suggest caffeine exaggerates the postprandial hyperglycemia and hyperinsulinemia present in these patients.
The experimental (non-treatment) studies in this project include double-blind placebo-controlled cross-over laboratory tests of glucose tolerance in groups of type 2 diabetic patients and prediabetic volunteers who are coffee drinkers.
The lab studies test the hypothesis that caffeine (vs. placebo) increases postprandial insulin responses and results in a potentiation of glucose responses in the type 2 group.
An ambulatory study examines the effects of caffeine administration on glucose levels during everyday activities in the natural environment. This study uses a double-blind placebo-controlled cross-over design. Ambulatory glucose data are collected with a MiniMed CGMS sensor and recorder worn for 72 hours. Caffeine and placebo are administered on separate days. Average glucose levels and glucose responses to meals are compared across treatment days within subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 6 months or longer history of type 2 diabetes
- treatment by diet, exercise, or oral medication
- current daily consumption of 2 or more cups of coffee
- BMI >21kg/M2 and < 45kg/M2
Key exclusion criteria (5 listed)
- Required use of insulin
- Current cigarette smoking
- Current use of medications that impact glucose metabolism
- Pregnancy
- Other major medical 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 |
|---|---|---|
| caffeine administration | Drug | – |
Primary outcome
postprandial glucose and insulin
fasting glucose and insulin
insulin resistance
glucose tolerance
5 secondary outcomes
epinephrine
norepinephrine
cortisol
blood pressure
plasma caffeine concentration
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 2 Mar 2010.
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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 D. Lane, Ph.D. principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing caffeine administration in people with Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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 4 inclusion and 5 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 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postprandial glucose and insulin. The study lists 4 primary outcomes in all. 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 2 Mar 2010.