- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03510624
Acute Effect of Rebaudioside A on Glucose Excursion During an Oral Glucose Tolerance Test in Type 2 Diabetes Mellitus (AREBAG)
April 27, 2021 updated by: Universitaire Ziekenhuizen KU Leuven
Investigation of the Acute Effect of Rebaudioside A on the Glucose Excursion During an Oral Glucose Tolerance Test in 30 Patients With Type 2 Diabetes Mellitus (AREBAG)
Investigate the acute effect of the steviol glycoside, rebaudioside A, on the glucose excursion during an oral glucose tolerance test in 30 patients with type 2 diabetes mellitus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Eligible individuals with type 2 diabetes mellitus will be invited for four study visits.
During the first and third study visit, rebaudioside A or the placebo will be administered.
During the second and fourth study visit, an oral glucose tolerance test (OGTT) will be executed to measure the response of administration of rebaudioside A versus placebo on the glucose homeostasis.
The area under the curve blood glucose values during the first two hours of the OGTT will be compared for both conditions.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
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
-
-
Flanders
-
Leuven, Flanders, Belgium, 3000
- Centrum Clinical Pharmacology
-
-
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
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed and dated written informed consent
- Understand procedures
- Type 2 diabetes mellitus
- Body Mass Index (BMI): 25 - 40 kg/m2
- HbA1c: 6.5-8%
- Judged to be in good health
Exclusion Criteria:
Subject is unable to
- Refrain from stevia leaves, stevia extracts or steviol glycoside-containing products from 5 days prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
- Refrain from quinine-containing products from 72h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
- Maintain their habitual diets and physical activity patterns and refrain from engaging in strenuous physical activities from 72h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
- Refrain from grapefruit products from 14 days before study visit 1 until discharge from the unit after the OGTT on study visit 4.
- Refrain from alcohol from 24h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
- Refrain from caffeine containing products from 12h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
- Fast at least 5 hours prior to the administration of rebaudioside A or placebo on study days 1 and 3.
- Fast at least 10 hours prior to the study days 2 and 4.
- Women of childbearing potential (last menstruation less than 1 year prior to screening) who are pregnant, lactating or planning to become pregnant during the study.
- Individuals with other forms of diabetes
- Current or previous treatment with any diabetes drug within 3 months prior to screening, except for metformin.
- Symptomatic hyperglycemia requiring immediate therapy during screening, in the judgement of the principal investigator.
- Evidence of significant diabetic complications.
- History of pancreas or beta-cell transplantation.
- Presence or history of clinically relevant medical, surgical or psychiatric conditions likely to affect the subject's safety in this trial or that could confound the study assessments or endpoints.
- Clinically relevant abnormal physical findings.
Clinically significant abnormalities of vital signs:
- Seated systolic blood pressure outside 90-160 mmHg
- Diastolic blood pressure outside 40-100 mmHg
- Heart rate <50 bpm
- Corrected QT (QTC) using Fridericia's formulae >450 msec (for men) or >470 msec (for women) measured with a 12-lead electrocardiogram.
- Clinically significant abnormal laboratory values.
- Moderate or severe renal dysfunction defined as a calculated glomerular filtration rate (GFR) <30 ml/min.
- Currently active or history of alcohol abuse.
- Currently active or history of drug addiction or currently a regular user of drugs including "recreational use" of any illicit drug.
- Smoking cigarettes or using nicotine-containing products, during the last 6 months prior to screening, as nicotine inhibits the Transient Receptor Potential 5 (TRPM5) channel.
- Individuals for whom a major surgery is planned to occur between screening and the end of the trial.
- Previous or current use of concomitant medication, which would confound the study conduct or implicate a risk for safety of the participant, as judged by the investigator(s).
- History of relevant drug or food allergies or a history of severe anaphylactic reaction.
- History of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.
- Individuals with hepatitis B and/or hepatitis C virus.
- Individuals with Human Immunodeficiency Virus (HIV).
- Participation in another clinical trial involving an investigational product within the 3 months preceding screening or 5-halflives of the drug studied, whichever is longer, prior to study supplement administration. Or, participation in any other type of medical research within 3 months preceding screening judged not to be scientifically or medically compatible with this study.
- Individuals who have donated or lost more than 500 ml blood or plasma within 3 months prior to screening.
- Individuals unable to swallow orally administered medication.
- Individuals in which catheter placement is impossible (amputation, no visible veins, …)
- Individuals that cannot speak or understand the Dutch language.
- In the opinion of the principal investigator any other factor that could interfere with the subject's ability to provide informed consent or to complete the study with strict compliance to the study protocol, or that could hold safety concerns for the subject or could impact the outcome of the study results.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: First rebaudioside A and then placebo
|
Rebaudioside A 3g
Empty capsules
|
Experimental: First placebo and then rebaudioside A
|
Rebaudioside A 3g
Empty capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve (AUC) blood glucose concentrations during an OGTT
Time Frame: 0 to 2 hours after glucose challenge
|
Area under the curve blood glucose concentrations during an OGTT
|
0 to 2 hours after glucose challenge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC glucose/insulin/glucagon
Time Frame: -30 to 0 min of OGTT
|
AUC glucose/insulin/glucagon
|
-30 to 0 min of OGTT
|
AUC glucose/insulin/glucagon
Time Frame: 0 to 30 min of OGTT
|
AUC glucose/insulin/glucagon
|
0 to 30 min of OGTT
|
AUC glucose/insulin/glucagon
Time Frame: 0 to 4 hours of OGTT
|
AUC glucose/insulin/glucagon
|
0 to 4 hours of OGTT
|
Maximal blood glucose
Time Frame: -30 min to 4 hours of OGTT
|
Maximal blood glucose
|
-30 min to 4 hours of OGTT
|
Maximal blood glucose excursion
Time Frame: -30 min to 4 hours of OGTT
|
Maximal blood glucose excursion
|
-30 min to 4 hours of OGTT
|
Maximal serum insulin
Time Frame: -30 min to 4 hours of OGTT
|
Maximal serum insulin
|
-30 min to 4 hours of OGTT
|
Maximal serum glucagon
Time Frame: -30 min to 4 hours of OGTT
|
Maximal serum glucagon
|
-30 min to 4 hours of OGTT
|
Concentration(t) (C(t))rebaudioside A, steviol and steviol glucuronide
Time Frame: -30 min to 4 hours of OGTT
|
Concentration of rebaudioside A, steviol and steviol glucuronide on different time points
|
-30 min to 4 hours of OGTT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bart Van der Schueren, UZ Leuven
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
November 9, 2018
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
April 17, 2018
First Submitted That Met QC Criteria
April 17, 2018
First Posted (Actual)
April 27, 2018
Study Record Updates
Last Update Posted (Actual)
April 28, 2021
Last Update Submitted That Met QC Criteria
April 27, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- s61580
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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