- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237314
The Impact of Food on Blood Sugar in People With Type 2 Diabetes (REACT2)
November 30, 2015 updated by: HealthPartners Institute
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55416
- International Diabetes Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants in Clinical Trials Study NCT01089569
Description
Inclusion Criteria:
- Study participants who are consented for the primary study and have not yet done the baseline CGM data collection at week -2-0.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maggie Powers, PhD, International Diabetes Center at Park Nicollet
- Principal Investigator: Alice Shapiro, PhD, International Diabetes Center at Park Nicollet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
November 5, 2010
First Submitted That Met QC Criteria
November 8, 2010
First Posted (Estimate)
November 9, 2010
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04037-10-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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