Type 2 DiabetesREACT2NCT01237314
The Impact of Food on Blood Sugar in People With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.
Trial summary
This study will record the impact of food on blood glucose levels using continuous glucose monitoring (CGM). The investigators think the impact will improve as medication doses are adjusted. The investigators also think that the impact will differ depending on the type of medication taken. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to May 2013
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in Clinical Trials Study NCT01089569
Who may be able to join
- Study participants who are consented for the primary study and have not yet done the baseline CGM data collection at week -2-0.
Who cannot join
- Study participants who are unable to complete the baseline CGM data collection at week -2-0.
- Study participants who are allergic to or have a food intolerance to any of the foods in the fixed meal
Trial locations and contacts
1 site in 1 country.
United States1 site
International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
Official title: Evaluation of the Glycemic Impact of Food in Patients With Type 2 Diabetes Taking Glargine and/or Exenatide
This study will record the impact of food on blood glucose levels using continuous glucose monitoring (CGM).
The investigators think the impact will improve as medication doses are adjusted. The investigators also think that the impact will differ depending on the type of medication taken.
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, metformin, glargine, exenatide, glycemic impact of food, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glargine Group | After baseline titration of metformin, this group will take glargine along with metformin. | |
| Exenatide Group | After baseline titration of metformin, this group will take exenatide along with metformin. | |
| Glargine and Exenatide Group | After baseline titration of metformin, this group will take glargine and exenatide along with metformin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-hour glycemic response at 3 time points
The four-hour glycemic response includes: four-hour post-meal area under the median interstitial glucose curve, post-meal interstitial glucose peak, time to peak, time to return to pre-prandial level (to within 10% of baseline with a maximum of the 4-hour post-meal fast), difference between peak and baseline, average rate of change in interstitial glucose across the 4 hour post-meal period, and percent of the 4-hour post-meal glucose readings >180 mg/dL.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2013
- Study completionMay 2013
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Sanofi
- Responsible party
- Sponsor
- Investigators
- Maggie Powers, PhD, Principal investigator, International Diabetes Center at Park NicolletAlice Shapiro, PhD, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237314
- Sponsor's protocol ID
- 04037-10-C
- Acronym
- REACT2
- Status last verified
- Apr 2013
- First submitted
- 5 Nov 2010
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Glycemic Impact of Food in Patients With Type 2 Diabetes Taking Glargine and/or Exenatide
- ClinicalTrials.gov ID
- NCT01237314
- Acronym / sponsor ID
- REACT2 / 04037-10-C
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, metformin, glargine, exenatide, glycemic impact of food, continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Sanofi
- Study start
- Nov 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 Nov 2010 (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 study will record the impact of food on blood glucose levels using continuous glucose monitoring (CGM).
The investigators think the impact will improve as medication doses are adjusted. The investigators also think that the impact will differ depending on the type of medication taken.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glargine Group | – | –After baseline titration of metformin, this group will take glargine along with metformin. |
| Exenatide Group | – | –After baseline titration of metformin, this group will take exenatide along with metformin. |
| Glargine and Exenatide Group | – | –After baseline titration of metformin, this group will take glargine and exenatide along with metformin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in Clinical Trials Study NCT01089569
Key inclusion criteria (1 listed)
- Study participants who are consented for the primary study and have not yet done the baseline CGM data collection at week -2-0.
Key exclusion criteria (2 listed)
- Study participants who are unable to complete the baseline CGM data collection at week -2-0.
- Study participants who are allergic to or have a food intolerance to any of the foods in the fixed meal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
4-hour glycemic response at 3 time points
Time frame: 4 hours
The four-hour glycemic response includes: four-hour post-meal area under the median interstitial glucose curve, post-meal interstitial glucose peak, time to peak, time to return to pre-prandial level (to within 10% of baseline with a maximum of the 4-hour post-meal fast), difference between peak and baseline, average rate of change in interstitial glucose across the 4 hour post-meal period, and percent of the 4-hour post-meal glucose readings >180 mg/dL.
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 Dec 2015.
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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.
Maggie Powers, PhD principal investigator
International Diabetes Center at Park Nicollet
Alice Shapiro, PhD principal investigator
International Diabetes Center at Park Nicollet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by HealthPartners Institute 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 1 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 2 Dec 2015. 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?
4-hour glycemic response at 3 time points (time frame: 4 hours). 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 Dec 2015.