- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04147273
Determination of Postprandial Glycemic Responses by Continuous Glucose Monitoring in a Real-World Setting
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Duesseldorf, Germany, 40591
- West-German Center of Diabetes and Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-80 years old
Exclusion Criteria:
- acute diseases, severe illness with in-patient treatment during the last 3 months, weight change >2 kg/week during the last month, smoking secession during the last 3 months, drugs for active weight reduction, chronic medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Evaluation of CGM compared with standard measurements
Two products were studied: white bread (Butter Toast®, Golden Toast, Wittenberg, Germany) and whole grain bread (1688 Mehrkorn®, Harry-Brot, Schenefeld, Germany).
One portion (containing 50 g digestible carbohydrates) was eaten immediately before the beginning of the test in the morning after an overnight fast of at least 10 h.
Before testing, participants ate as usual on the previous day without a standard meal and refrained from consuming alcohol and exercising for 72 h.
A 200-ml glucose drink (Accu-Chek Dextrose O.G.-T.
Saft®, Roche Diabetes Care, Mannheim, Germany), containing also 50 g of carbohydrates, was used as the reference product.
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One day prior to the study beginning, participants were equipped with a CGM system (FreeStyle Libre®, Abbott Diabetes Care, Alameda, CA, USA). This CGM system provides glucose recordings every 15 min over a period of 14 days. The glucose data were downloaded manually by a scan with a handheld device. On the second day of the study, participants consumed portions of these three test products containing 50 g of available carbohydrate on 3 separate days without a washout period. The products were tested in random order at the same time of the morning after a 10 h overnight fast. Venous blood samples were collected at 0, 15, 30, 45, 60, 75, 90, 105 and 120 min postprandial by inserting an intravenous cannula into a forearm vein. Capillary blood samples were obtained through finger pricking. Blood glucose levels in these samples were measured with a high quality SMBG system (ContourXT/Contour next, Ascensia Diabetes Care, Leverkusen, Deutschland, Germany). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial glucose response
Time Frame: 1 and 2 hours after food consumption
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postprandial glycemic changes after consuming different carbohydrate containing foods
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1 and 2 hours after food consumption
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incremental AUC (AUCi) of postprandial glucose excursions
Time Frame: 1 and 2 hours after food consumption
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after consuming different carbohydrate containing foods
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1 and 2 hours after food consumption
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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